Trial Outcomes & Findings for Perioperative Active Warming Techniques in Colorectal Surgeries (NCT NCT00913978)

NCT ID: NCT00913978

Last Updated: 2020-01-13

Results Overview

The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2020-01-13

Participant Flow

50 patients were consented to participate, 4 were withdrawn from the study to leave an analysis sample of 46 subjects. The study was terminated early due to financial constraints from the sponsor.

Participant milestones

Measure	Group 1: VitaHeat Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Group 2: Bair Hugger Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Overall Study STARTED	26	24
Overall Study COMPLETED	25	21
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Group 1: VitaHeat Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Group 2: Bair Hugger Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Overall Study Surgeon choice	1	3

Baseline Characteristics

Perioperative Active Warming Techniques in Colorectal Surgeries

Baseline characteristics by cohort

Measure	Group 1: VitaHeat n=25 Participants Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Group 2: Bair Hugger n=21 Participants Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Total n=46 Participants Total of all reporting groups
Age, Continuous	58.36 Years n=5 Participants	60.76 Years n=7 Participants	59.5 Years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	21 participants n=7 Participants	46 participants n=5 Participants
Weight in kilogram (kg)	78.55 kilograms n=5 Participants	78.76 kilograms n=7 Participants	78.65 kilograms n=5 Participants
Length of hospital stay in days	3.88 Days n=5 Participants	3.1 Days n=7 Participants	3.5 Days n=5 Participants

PRIMARY outcome

Timeframe: 1 day

The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.

Outcome measures

Measure	Group 1: VitaHeat n=25 Participants Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Group 2: Bair Hugger n=21 Participants Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.	47.1 percent time Interval 0.0 to 100.0	72.0 percent time Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Immediately after surgery

Population: 1 subject from the VITAheat group and 3 subjects from the Bair hugger group were excluded from analysis.

Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed.

Outcome measures

Measure	Group 1: VitaHeat n=25 Participants Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Group 2: Bair Hugger n=21 Participants Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Post Operative Temperature on Admission to Post Operative Care Unit (PACU)	36.6 Degrees Celcius Interval 35.0 to 37.3	36.8 Degrees Celcius Interval 36.4 to 37.2

Adverse Events

Group 1: VitaHeat

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 2: Bair Hugger

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: VitaHeat n=25 participants at risk Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Group 2: Bair Hugger n=21 participants at risk Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Cardiac disorders Myocardial infarction	0.00% 0/25 • Up to 30 days after surgical procedure.	0.00% 0/21 • Up to 30 days after surgical procedure.
Cardiac disorders Cardiac Arrest	0.00% 0/25 • Up to 30 days after surgical procedure.	0.00% 0/21 • Up to 30 days after surgical procedure.

Other adverse events

Measure	Group 1: VitaHeat n=25 participants at risk Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.	Group 2: Bair Hugger n=21 participants at risk Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Renal and urinary disorders Urinary tract infection	12.0% 3/25 • Number of events 3 • Up to 30 days after surgical procedure.	0.00% 0/21 • Up to 30 days after surgical procedure.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/25 • Up to 30 days after surgical procedure.	0.00% 0/21 • Up to 30 days after surgical procedure.
Renal and urinary disorders Bladder injury	0.00% 0/25 • Up to 30 days after surgical procedure.	4.8% 1/21 • Number of events 1 • Up to 30 days after surgical procedure.
Vascular disorders Deep vein thrombosis	0.00% 0/25 • Up to 30 days after surgical procedure.	4.8% 1/21 • Number of events 1 • Up to 30 days after surgical procedure.
Respiratory, thoracic and mediastinal disorders Device burn injury to skin	0.00% 0/25 • Up to 30 days after surgical procedure.	0.00% 0/21 • Up to 30 days after surgical procedure.

Additional Information

Meltem Yilmaz, MD

Northwestern University

Phone: 312-695-0061

Email: m-yilmaz@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place