Trial Outcomes & Findings for Effect of Standard Normothermia Protocol On Surgical Site Infections (NCT NCT02961244)
NCT ID: NCT02961244
Last Updated: 2017-12-12
Results Overview
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n\<30), (p=0.044 chi-square )
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
Postoperative 30 days
Results posted on
2017-12-12
Participant Flow
Between June 2013 and December 2015 elective, preoperatively not infected/dirty, open major abdominal operations under general anesthesia, longer than 30 minutes and over 18 aged were included in the study. Primary outcome was comparison of SSI rates between groups and secondary was effects of protocol to normothermia.
Exclusion criteria were emergent surgery, local/locoregional procedures, laparoscopic operations, minor abdominal operations, malign hyperthermia, signs of active infection/fever, immunosuppression, malnutrition, kidney/liver failure, antibiotic use within the previous 1 week/ımmunsupresive use within previous 1 month, reversal of approval.
Participant milestones
| Measure |
Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
Patients Excluded During Randomization
|
0
|
1
|
|
Overall Study
COMPLETED
|
63
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
| Measure |
Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Surgery plan change after study approval
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
İnadequate data
|
0
|
2
|
Baseline Characteristics
For patients only had had epidural catheter inserted.
Baseline characteristics by cohort
| Measure |
Control Group
n=63 Patients
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
Intervention Group
n=55 Patients
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
|
Total
n=118 Patients
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 14.3 • n=63 Participants
|
57.6 years
STANDARD_DEVIATION 12.9 • n=55 Participants
|
57.8 years
STANDARD_DEVIATION 13.6 • n=118 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=63 Participants
|
23 Participants
n=55 Participants
|
57 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=63 Participants
|
32 Participants
n=55 Participants
|
61 Participants
n=118 Participants
|
|
BMI
|
26.6 kilograms per square meter
STANDARD_DEVIATION 4.9 • n=63 Participants
|
26.8 kilograms per square meter
STANDARD_DEVIATION 4.4 • n=55 Participants
|
26.7 kilograms per square meter
STANDARD_DEVIATION 4.7 • n=118 Participants
|
|
Weight
|
72.8 kilograms
STANDARD_DEVIATION 14.9 • n=63 Participants
|
75.3 kilograms
STANDARD_DEVIATION 14.5 • n=55 Participants
|
74 kilograms
STANDARD_DEVIATION 14.7 • n=118 Participants
|
|
Height
|
165.1 centimeters
STANDARD_DEVIATION 8.6 • n=63 Participants
|
167.3 centimeters
STANDARD_DEVIATION 8.7 • n=55 Participants
|
166.0 centimeters
STANDARD_DEVIATION 8.0 • n=118 Participants
|
|
Ethiology
Hepatopancreaticobiliary System Etiology
|
24 Participants
n=63 Participants
|
10 Participants
n=55 Participants
|
34 Participants
n=118 Participants
|
|
Ethiology
Colorectal Tract Etiology
|
32 Participants
n=63 Participants
|
32 Participants
n=55 Participants
|
64 Participants
n=118 Participants
|
|
Ethiology
Upper Gastointestinal Tract
|
7 Participants
n=63 Participants
|
13 Participants
n=55 Participants
|
20 Participants
n=118 Participants
|
|
Smoking habit
Nonsmoker
|
30 Participants
n=63 Participants
|
26 Participants
n=55 Participants
|
56 Participants
n=118 Participants
|
|
Smoking habit
Smoking History
|
33 Participants
n=63 Participants
|
29 Participants
n=55 Participants
|
62 Participants
n=118 Participants
|
|
Alcohol Use
Alcohol use (<2 glass)
|
61 Participants
n=63 Participants
|
52 Participants
n=55 Participants
|
113 Participants
n=118 Participants
|
|
Alcohol Use
Alcohol use (≥2 glass)
|
2 Participants
n=63 Participants
|
3 Participants
n=55 Participants
|
5 Participants
n=118 Participants
|
|
Type of anesthesia
General anesthesia
|
16 Participants
n=63 Participants
|
15 Participants
n=55 Participants
|
31 Participants
n=118 Participants
|
|
Type of anesthesia
General and epidural anesthesia
|
29 Participants
n=63 Participants
|
20 Participants
n=55 Participants
|
49 Participants
n=118 Participants
|
|
Type of anesthesia
General and intrathecal anesthesia
|
18 Participants
n=63 Participants
|
20 Participants
n=55 Participants
|
38 Participants
n=118 Participants
|
|
Epidural catheter removal time if any inserted
|
5.07 days
STANDARD_DEVIATION 2.3 • n=29 Participants • For patients only had had epidural catheter inserted.
|
5.09 days
STANDARD_DEVIATION 2 • n=20 Participants • For patients only had had epidural catheter inserted.
|
5.08 days
STANDARD_DEVIATION 2.2 • n=49 Participants • For patients only had had epidural catheter inserted.
|
|
Central venous access
Not used
|
18 Participants
n=63 Participants
|
21 Participants
n=55 Participants
|
39 Participants
n=118 Participants
|
|
Central venous access
Used temporary methods
|
33 Participants
n=63 Participants
|
20 Participants
n=55 Participants
|
53 Participants
n=118 Participants
|
|
Central venous access
Permenant central venous port previously inserted
|
12 Participants
n=63 Participants
|
14 Participants
n=55 Participants
|
26 Participants
n=118 Participants
|
|
If only temporary, removal time of central venous catheter
|
6.09 days
STANDARD_DEVIATION 3.7 • n=33 Participants • For patients only had had temporary central venous catheter inserted.
|
7.2 days
STANDARD_DEVIATION 2.6 • n=20 Participants • For patients only had had temporary central venous catheter inserted.
|
6.5 days
STANDARD_DEVIATION 3.4 • n=53 Participants • For patients only had had temporary central venous catheter inserted.
|
|
Operating Room Temperature
|
21.3 ºC degrees
STANDARD_DEVIATION 2 • n=63 Patients
|
21.5 ºC degrees
STANDARD_DEVIATION 2 • n=55 Patients
|
21.4 ºC degrees
STANDARD_DEVIATION 2 • n=118 Patients
|
|
İntraoperative blood loss
|
0.23 liters
STANDARD_DEVIATION 0.3 • n=63 Participants
|
0.26 liters
STANDARD_DEVIATION 0.36 • n=55 Participants
|
0.24 liters
STANDARD_DEVIATION 0.33 • n=118 Participants
|
|
İntraoperative red cell transfusion
|
0.24 units
STANDARD_DEVIATION 0.58 • n=63 Participants
|
0.33 units
STANDARD_DEVIATION 0.74 • n=55 Participants
|
0.25 units
STANDARD_DEVIATION 0.6 • n=118 Participants
|
|
Intraoperative fresh frozen plasma transfusion
|
0 units
STANDARD_DEVIATION 0 • n=63 Participants
|
0.018 units
STANDARD_DEVIATION 0.134 • n=55 Participants
|
0.008 units
STANDARD_DEVIATION 0.009 • n=118 Participants
|
|
Intraoperative cristalloid fluid
|
3.06 liters
STANDARD_DEVIATION 1.38 • n=63 Participants
|
3.01 liters
STANDARD_DEVIATION 1.4 • n=55 Participants
|
3.04 liters
STANDARD_DEVIATION 1.38 • n=118 Participants
|
|
Intraoperative colloid fluid
|
0.42 liters
STANDARD_DEVIATION 0.57 • n=63 Participants
|
0.33 liters
STANDARD_DEVIATION 0.42 • n=55 Participants
|
0.38 liters
STANDARD_DEVIATION 0.5 • n=118 Participants
|
|
Intraoperative urine output
|
0.77 liters
STANDARD_DEVIATION 0.71 • n=63 Participants
|
0.7 liters
STANDARD_DEVIATION 0.57 • n=55 Participants
|
0.74 liters
STANDARD_DEVIATION 0.64 • n=118 Participants
|
|
Mean heart rate
|
78 beats per minute
STANDARD_DEVIATION 13.4 • n=63 Participants
|
75.8 beats per minute
STANDARD_DEVIATION 14.5 • n=55 Participants
|
77 beats per minute
STANDARD_DEVIATION 13.9 • n=118 Participants
|
|
Intraoperative mean arterial blood pressure
|
89.1 mm Hg
STANDARD_DEVIATION 13.2 • n=63 Participants
|
87 mm Hg
STANDARD_DEVIATION 7 • n=55 Participants
|
88.1 mm Hg
STANDARD_DEVIATION 13.4 • n=118 Participants
|
|
Operation duration
|
239.6 minutes
STANDARD_DEVIATION 118.3 • n=63 Participants
|
199.9 minutes
STANDARD_DEVIATION 106.3 • n=55 Participants
|
221.1 minutes
STANDARD_DEVIATION 114 • n=118 Participants
|
|
Perioperative hemoglobin levels
Preoperative
|
11.81 g/dl
STANDARD_DEVIATION 1.49 • n=63 Participants
|
11.8 g/dl
STANDARD_DEVIATION 1.35 • n=55 Participants
|
11.81 g/dl
STANDARD_DEVIATION 1.42 • n=118 Participants
|
|
Perioperative hemoglobin levels
Postoperative 1. Day
|
11.0 g/dl
STANDARD_DEVIATION 1.58 • n=63 Participants
|
11.19 g/dl
STANDARD_DEVIATION 1.54 • n=55 Participants
|
11.09 g/dl
STANDARD_DEVIATION 1.55 • n=118 Participants
|
|
Perioperative hemoglobin levels
∆(Hemoglobin)
|
0.80 g/dl
STANDARD_DEVIATION 1.22 • n=63 Participants
|
0.61 g/dl
STANDARD_DEVIATION 1.10 • n=55 Participants
|
0.71 g/dl
STANDARD_DEVIATION 1.16 • n=118 Participants
|
|
Perioperative albumin levels
Preoperative
|
3.74 g/dl
STANDARD_DEVIATION 0.46 • n=63 Participants
|
3.66 g/dl
STANDARD_DEVIATION 0.5 • n=55 Participants
|
3.71 g/dl
STANDARD_DEVIATION 0.48 • n=118 Participants
|
|
Perioperative albumin levels
Postoperative 1. Day
|
2.86 g/dl
STANDARD_DEVIATION 0.56 • n=63 Participants
|
2.96 g/dl
STANDARD_DEVIATION 0.5 • n=55 Participants
|
2.91 g/dl
STANDARD_DEVIATION 0.53 • n=118 Participants
|
|
Perioperative albumin levels
∆(Albumin)
|
0.88 g/dl
STANDARD_DEVIATION 0.51 • n=63 Participants
|
0.69 g/dl
STANDARD_DEVIATION 0.5 • n=55 Participants
|
0.79 g/dl
STANDARD_DEVIATION 0.51 • n=118 Participants
|
|
Profilactic antibiotics
Cefazolin
|
30 Participants
n=63 Participants
|
22 Participants
n=55 Participants
|
52 Participants
n=118 Participants
|
|
Profilactic antibiotics
Cefuroxime + metronidazole
|
30 Participants
n=63 Participants
|
32 Participants
n=55 Participants
|
62 Participants
n=118 Participants
|
|
Profilactic antibiotics
Ceftriaxone
|
1 Participants
n=63 Participants
|
1 Participants
n=55 Participants
|
2 Participants
n=118 Participants
|
|
Profilactic antibiotics
Ceftriaxone+ metronidazole
|
1 Participants
n=63 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=118 Participants
|
|
Profilactic antibiotics
Amoxicillin + clavulanate
|
1 Participants
n=63 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=118 Participants
|
|
Duration of Hospitalization Parameters
Total Duration of Hospitalization
|
18.96 days
STANDARD_DEVIATION 18.62 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
19.4 days
STANDARD_DEVIATION 10.49 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
19.25 days
STANDARD_DEVIATION 15.28 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
|
Duration of Hospitalization Parameters
Preoperative Duration of Hospitalization
|
6.87 days
STANDARD_DEVIATION 5.91 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
7.47 days
STANDARD_DEVIATION 6.49 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
7.15 days
STANDARD_DEVIATION 6.17 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
|
Duration of Hospitalization Parameters
Postoperative Duration of Hospitalization
|
12.09 days
STANDARD_DEVIATION 15.54 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
12.1 days
STANDARD_DEVIATION 9.07 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
12.1 days
STANDARD_DEVIATION 12.88 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
|
Duration of Hospitalization Parameters
Duration of ICU Hospitalization
|
3.5 days
STANDARD_DEVIATION 5.68 • n=16 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
3.45 days
STANDARD_DEVIATION 7.48 • n=11 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
3.48 days
STANDARD_DEVIATION 6.33 • n=27 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
|
|
Simple Hospitalization costs
|
12.6 Thousand Turkish liras
STANDARD_DEVIATION 9.8 • n=63 Participants
|
11.7 Thousand Turkish liras
STANDARD_DEVIATION 6.1 • n=55 Participants
|
12.2 Thousand Turkish liras
STANDARD_DEVIATION 8.3 • n=118 Participants
|
|
Perioperative Warming
Peroperatuar Warming
|
63 participants
n=63 Participants • Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
|
55 participants
n=55 Participants • Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
|
118 participants
n=118 Participants • Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
|
|
Perioperative Warming
Postoperative Warming
|
13 participants
n=13 Participants • Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
|
47 participants
n=55 Participants • Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
|
60 participants
n=68 Participants • Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
|
|
Surgical Site Classification
Clean
|
4 Participants
n=63 Participants
|
2 Participants
n=55 Participants
|
6 Participants
n=118 Participants
|
|
Surgical Site Classification
Clean-Contaminated
|
58 Participants
n=63 Participants
|
52 Participants
n=55 Participants
|
110 Participants
n=118 Participants
|
|
Surgical Site Classification
Contaminated
|
1 Participants
n=63 Participants
|
1 Participants
n=55 Participants
|
2 Participants
n=118 Participants
|
|
ASA Score
ASA 1
|
22 Participants
n=63 Participants
|
19 Participants
n=55 Participants
|
41 Participants
n=118 Participants
|
|
ASA Score
ASA 2
|
32 Participants
n=63 Participants
|
29 Participants
n=55 Participants
|
61 Participants
n=118 Participants
|
|
ASA Score
ASA 3
|
9 Participants
n=63 Participants
|
7 Participants
n=55 Participants
|
16 Participants
n=118 Participants
|
|
NNISS Score
<2
|
52 Participants
n=63 Participants
|
46 Participants
n=55 Participants
|
98 Participants
n=118 Participants
|
|
NNISS Score
≥2
|
11 Participants
n=63 Participants
|
9 Participants
n=55 Participants
|
20 Participants
n=118 Participants
|
|
SENIC Score
<3
|
57 Participants
n=63 Participants
|
48 Participants
n=55 Participants
|
105 Participants
n=118 Participants
|
|
SENIC Score
≥3
|
6 Participants
n=63 Participants
|
7 Participants
n=55 Participants
|
13 Participants
n=118 Participants
|
|
Comorbidities
Congestive Heart Failure
|
1 Participants
n=63 Participants
|
2 Participants
n=55 Participants
|
3 Participants
n=118 Participants
|
|
Comorbidities
Pulmonary Circulation Disorders
|
0 Participants
n=63 Participants
|
5 Participants
n=55 Participants
|
5 Participants
n=118 Participants
|
|
Comorbidities
Complicated Hypertension
|
2 Participants
n=63 Participants
|
4 Participants
n=55 Participants
|
6 Participants
n=118 Participants
|
|
Comorbidities
Uncomplicated Hypertension
|
19 Participants
n=63 Participants
|
19 Participants
n=55 Participants
|
38 Participants
n=118 Participants
|
|
Comorbidities
Chronic Respiratory Diseases
|
2 Participants
n=63 Participants
|
4 Participants
n=55 Participants
|
6 Participants
n=118 Participants
|
|
Comorbidities
Uncomplicated Diabetes
|
11 Participants
n=63 Participants
|
10 Participants
n=55 Participants
|
21 Participants
n=118 Participants
|
|
Comorbidities
Complicated Diabetes
|
0 Participants
n=63 Participants
|
3 Participants
n=55 Participants
|
3 Participants
n=118 Participants
|
|
Comorbidities
Hypothyroidism
|
8 Participants
n=63 Participants
|
3 Participants
n=55 Participants
|
11 Participants
n=118 Participants
|
|
Comorbidities
Lymphoma
|
1 Participants
n=63 Participants
|
1 Participants
n=55 Participants
|
2 Participants
n=118 Participants
|
|
Comorbidities
Metastatic Cancer
|
16 Participants
n=63 Participants
|
11 Participants
n=55 Participants
|
27 Participants
n=118 Participants
|
|
Comorbidities
Non-metastatic Solid Tumor
|
45 Participants
n=63 Participants
|
43 Participants
n=55 Participants
|
88 Participants
n=118 Participants
|
|
Comorbidities
Other(Valvuler, collagen tissue, etc diseases)
|
4 Participants
n=63 Participants
|
1 Participants
n=55 Participants
|
5 Participants
n=118 Participants
|
|
Perioperative Temperature Measurements
Perioperative Minimum Measurement
|
35.17 ºC degrees
STANDARD_DEVIATION 0.59 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
35.76 ºC degrees
STANDARD_DEVIATION 0.52 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
35.44 ºC degrees
STANDARD_DEVIATION 0.63 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Preoperative Room Enterance Temperature
|
36.94 ºC degrees
STANDARD_DEVIATION 0.47 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.94 ºC degrees
STANDARD_DEVIATION 0.46 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.94 ºC degrees
STANDARD_DEVIATION 0.46 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Preoperative Room Exit Temperature
|
37.03 ºC degrees
STANDARD_DEVIATION 0.4 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.89 ºC degrees
STANDARD_DEVIATION 0.5 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.96 ºC degrees
STANDARD_DEVIATION 0.46 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
After Entubation Temperature
|
36.36 ºC degrees
STANDARD_DEVIATION 0.6 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.66 ºC degrees
STANDARD_DEVIATION 0.46 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.5 ºC degrees
STANDARD_DEVIATION 0.56 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Postentubation 60. minutes Temperature
|
35.74 ºC degrees
STANDARD_DEVIATION 0.62 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.16 ºC degrees
STANDARD_DEVIATION 0.56 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
35.9 ºC degrees
STANDARD_DEVIATION 0.62 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Postentubation 120. minutes Temperature
|
35.8 ºC degrees
STANDARD_DEVIATION 0.73 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.28 ºC degrees
STANDARD_DEVIATION 0.6 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
35.9 ºC degrees
STANDARD_DEVIATION 0.76 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Postentubation 180. minutes Temperature
|
35.63 ºC degrees
STANDARD_DEVIATION 0.86 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.25 ºC degrees
STANDARD_DEVIATION 0.72 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
35.88 ºC degrees
STANDARD_DEVIATION 0.86 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Postentubation 240. minutes Temperature
|
35.5 ºC degrees
STANDARD_DEVIATION 0.82 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.45 ºC degrees
STANDARD_DEVIATION 0.87 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
35.85 ºC degrees
STANDARD_DEVIATION 0.95 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
After Extubation Temperature
|
35.88 ºC degrees
STANDARD_DEVIATION 0.74 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.54 ºC degrees
STANDARD_DEVIATION 0.67 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.21 ºC degrees
STANDARD_DEVIATION 0.77 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Recovery Room Enterance Temperature
|
35.84 ºC degrees
STANDARD_DEVIATION 0.75 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.41 ºC degrees
STANDARD_DEVIATION 0.64 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.12 ºC degrees
STANDARD_DEVIATION 0.75 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Recovery Room ExitTemperature
|
36.48 ºC degrees
STANDARD_DEVIATION 0.62 • n=63 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.7 ºC degrees
STANDARD_DEVIATION 0.61 • n=55 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.59 ºC degrees
STANDARD_DEVIATION 0.62 • n=118 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
Service Enterance Temperature
|
36.31 ºC degrees
STANDARD_DEVIATION 0.42 • n=47 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.35 ºC degrees
STANDARD_DEVIATION 0.38 • n=44 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.33 ºC degrees
STANDARD_DEVIATION 0.4 • n=91 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Perioperative Temperature Measurements
ICU Enterance Temperature (ICU patients)
|
35.78 ºC degrees
STANDARD_DEVIATION 0.95 • n=16 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
36.08 ºC degrees
STANDARD_DEVIATION 0.64 • n=11 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
35.89 ºC degrees
STANDARD_DEVIATION 0.85 • n=27 Participants • In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data. Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.
|
|
Infectious Complications
No İnfectious Complications
|
42 Participants
n=63 Participants
|
43 Participants
n=55 Participants
|
85 Participants
n=118 Participants
|
|
Infectious Complications
Pulmonary
|
4 Participants
n=63 Participants
|
1 Participants
n=55 Participants
|
5 Participants
n=118 Participants
|
|
Infectious Complications
Urinary
|
2 Participants
n=63 Participants
|
2 Participants
n=55 Participants
|
4 Participants
n=118 Participants
|
|
Infectious Complications
Bacteriemia
|
3 Participants
n=63 Participants
|
1 Participants
n=55 Participants
|
4 Participants
n=118 Participants
|
|
Infectious Complications
SSI
|
18 Participants
n=63 Participants
|
9 Participants
n=55 Participants
|
27 Participants
n=118 Participants
|
|
SSI Classification
Superficial Incisional
|
10 Participants
n=63 Participants
|
6 Participants
n=55 Participants
|
16 Participants
n=118 Participants
|
|
SSI Classification
Deep Incisional
|
3 Participants
n=63 Participants
|
1 Participants
n=55 Participants
|
4 Participants
n=118 Participants
|
|
SSI Classification
Organ-Space
|
5 Participants
n=63 Participants
|
2 Participants
n=55 Participants
|
7 Participants
n=118 Participants
|
|
ASEPSIS Total Scores
|
17.83 points
STANDARD_DEVIATION 13.83 • n=63 Participants
|
12.64 points
STANDARD_DEVIATION 10.6 • n=55 Participants
|
15.41 points
STANDARD_DEVIATION 12.67 • n=118 Participants
|
PRIMARY outcome
Timeframe: Postoperative 30 daysPopulation: Patients and their results assessed on the basis of intention to treat per protocole.
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n\<30), (p=0.044 chi-square )
Outcome measures
| Measure |
Control Group
n=63 Participants
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
Intervention Group
n=55 Participants
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
|
|---|---|---|
|
Surgical Site Infection Rate
|
19 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Surgery dayPopulation: Patients and their results assessed on the basis of intention to treat per protocole.
Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed. With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was \<36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia)
Outcome measures
| Measure |
Control Group
n=63 Participants
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
Intervention Group
n=55 Participants
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
|
|---|---|---|
|
Maintaining Normothermia Rate
|
7 Participants
|
26 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=63 participants at risk
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
Intervention Group
n=55 participants at risk
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket
|
|---|---|---|
|
Product Issues
Thermal Discomfort
|
0.00%
0/63 • Within the postoperative 30 days
|
1.8%
1/55 • Number of events 1 • Within the postoperative 30 days
|
Additional Information
Ali Kadir Degirmenci
Dokuz Eylul University Medicine Faculty, General Surgery Department
Phone: +902324122901
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place