Normothermia
Conditions
Keywords
Normothermia, Colorectal Surgery, Bair Huggers, VitaHeat
Brief summary
We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.
Detailed description
Stratified randomization will be performed using a computerized randomization table where the strata will be type of surgery (open vs closed) and the treatment will be forced air blanket or underbody mattress warming device. This will allow equal groups of both warming devices in both types of surgery. Group 1: 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. Group 2: 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. Both groups will have IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. Participation in the study is voluntary. The patients may choose not to enroll in the research. Patients who choose not to enroll will use the standard forced air warmer. Preoperative and postoperative temperatures will be measured orally. Intraoperative core and skin temperatures will be monitored continuously at 1 minute intervals using an esophageal probe and skin temperature probe using a skin temp probe placed on the great toe and covered to prevent any contact with the warming devices. Intraoperative period: The participants temperature will be monitored and documented at prescribed times. Postoperative period: The participants will have temperature monitored in the post anesthesia care area. Participation in this study will last for 30 days following surgery at which point study member will call patient for a 2-4 minute phone call.
Interventions
DEVICEGroup 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.
DEVICEGroup 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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years old undergoing laparoscopic or open colorectal surgical procedures under general anesthesia.
Exclusion criteria
* Any patient who is less than 18 years old. * Emergent surgery * Any patient with thyroid problems * Any patient with preoperative fever * Any patient who is pregnant * Any adult patients unable to consent * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Temperature on Admission to Post Operative Care Unit (PACU) | Immediately after surgery | Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 21 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Surgeon choice | 1 | 3 |
Baseline characteristics
| Characteristic | Group 1: VitaHeat | Group 2: Bair Hugger | Total |
|---|---|---|---|
| Age, Continuous | 58.36 Years | 60.76 Years | 59.5 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 21 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Length of hospital stay in days | 3.88 Days | 3.1 Days | 3.5 Days |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 21 Participants | 19 Participants | 40 Participants |
| Region of Enrollment United States | 25 participants | 21 participants | 46 participants |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
| Weight in kilogram (kg) | 78.55 kilograms | 78.76 kilograms | 78.65 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 21 |
| other Total, other adverse events | 3 / 25 | 2 / 21 |
| serious Total, serious adverse events | 0 / 25 | 0 / 21 |
Outcome results
Primary
The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: VitaHeat | The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius. | 47.1 percent time |
| Group 2: Bair Hugger | The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius. | 72.0 percent time |
Secondary
Post Operative Temperature on Admission to Post Operative Care Unit (PACU)
Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed.
Time frame: Immediately after surgery
Population: 1 subject from the VITAheat group and 3 subjects from the Bair hugger group were excluded from analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: VitaHeat | Post Operative Temperature on Admission to Post Operative Care Unit (PACU) | 36.6 Degrees Celcius |
| Group 2: Bair Hugger | Post Operative Temperature on Admission to Post Operative Care Unit (PACU) | 36.8 Degrees Celcius |