Trial Outcomes & Findings for Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients (NCT NCT01626690)
NCT ID: NCT01626690
Last Updated: 2016-08-15
Results Overview
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Results posted on
2016-08-15
Participant Flow
Participant milestones
| Measure |
Pre-Warming
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
47
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Pre-Warming
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
Baseline characteristics by cohort
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=51 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 7.41 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
51 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Baseline Temperature
|
36.6 Degrees Celisius
STANDARD_DEVIATION 0.4 • n=5 Participants
|
36.7 Degrees Celisius
STANDARD_DEVIATION 0.37 • n=7 Participants
|
36.6 Degrees Celisius
STANDARD_DEVIATION 0.39 • n=5 Participants
|
PRIMARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.
Outcome measures
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=51 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
|
35.7 Degrees Celsius
Standard Deviation 0.47
|
35.4 Degrees Celsius
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Outcome measures
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=51 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
|
36.7 Degrees Celsius
Standard Deviation 0.4
|
36.6 Degrees Celsius
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Outcome measures
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=51 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.
|
35.7 Degrees Celsius
Standard Deviation 0.4
|
35.4 Degrees Celsius
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Outcome measures
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=50 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.
|
35.4 Degrees Celsius
Standard Deviation 0.8
|
35.1 Degrees Celsius
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Outcome measures
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=51 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Incidence of Postoperative Shivering in Recovery Room.
|
1 Number of patients reporting shivering
|
14 Number of patients reporting shivering
|
SECONDARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Intraoperative blood loss in mL's.
Outcome measures
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=51 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Intraoperative Blood Loss.
|
263 mL
Standard Deviation 109
|
307 mL
Standard Deviation 116
|
SECONDARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Incidence of perioperative arrhythmias or myocardial ischemia.
Outcome measures
| Measure |
Pre-Warming
n=47 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=51 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Incidence of Perioperative Cardiac Events.
|
1 Patients
|
0 Patients
|
SECONDARY outcome
Timeframe: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.
Outcome measures
| Measure |
Pre-Warming
n=98 Participants
Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
|
Control
n=98 Participants
Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
|
|---|---|---|
|
Temporal Artery Verus SpotOn (3M) Temperature Readings.
|
36.5 Degrees Celsius
Standard Deviation 0.5
|
36.5 Degrees Celsius
Standard Deviation 0.5
|
Adverse Events
Pre-Warming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kristopher Schroeder, MD
University of Wisconsin School of Medicine and Public Health
Phone: 608-263-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place