Surgery
Conditions
Keywords
temperature, surgery, heating device
Brief summary
The primary objective of this study is to determine if the intraoperative distal esophageal (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in patients undergoing open colectomy under general anesthesia. This is a randomized study.
Detailed description
Participants will be randomized into one of two groups. Patients assigned to vitalHEAT warming will have the circulating-water sleeve applied to an arm that will not require intravenous access. An esophageal temperature probe will be inserted and connected to the anesthesia machine monitoring system. Intravenous fluids will be warmed to 40-42°C. As soon as practical after induction, the vitalHEAT warmer will be activated in the appropriate patients and set to high which is 42°C An upper-body forced-air warmer will be positioned over the upper body and exposed arms on patients assigned to forced-air heating. The forced air blower will be set to high which is 43°C and activated as soon as practical, usually after prepping and draping. Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Active warming will be maintained until just before extubation. The esophageal temperature probe will be removed, and the patient extubated after emergence from anesthesia. This will conclude the study and subsequent management will be at the discretion of the attending anesthesiologist
Interventions
DEVICEa forced-air warming cover
A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery.
DEVICEvital HEAT (vH2) Temperature Management System
The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Body-mass index 20-36 kg/m2; * Age 18-75 yrs; * ASA Physical Status 1-3.
Exclusion criteria
* Patient requires an intravenous or arterial catheter distal to the elbow on both arms; * Serious skin lesions on the hands or arms; * History of serious vascular disease in the arms; * Pre-operative fever; * Contraindication to sevoflurane endotracheal anesthesia. * Pre-existing neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative Distal Esophageal (Core) Temperature | at 1 hour |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Warm-water Sleeve The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.
vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery. | 37 |
| Forced Air Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.
a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery. | 34 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Forced Air | Warm-water Sleeve |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 15 | 50 years STANDARD_DEVIATION 15 | 48 years STANDARD_DEVIATION 15 |
| Body mass index | 26.2 kg/m^2 STANDARD_DEVIATION 6 | 26.3 kg/m^2 STANDARD_DEVIATION 5.3 | 26.1 kg/m^2 STANDARD_DEVIATION 6.6 |
| Race/Ethnicity, Customized African American | 2 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Unknown | 6 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized White | 63 participants | 31 participants | 32 participants |
| Sex/Gender, Customized Female | 25 participants | 14 participants | 11 participants |
| Sex/Gender, Customized Male | 41 participants | 18 participants | 23 participants |
| Sex/Gender, Customized Missing | 5 participants | 2 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 34 |
| serious Total, serious adverse events | 0 / 37 | 0 / 34 |
Outcome results
Primary
Intraoperative Distal Esophageal (Core) Temperature
Time frame: at 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warm-water Sleeve | Intraoperative Distal Esophageal (Core) Temperature | 35.96 °C | Standard Error 0.081 |
| Forced Air | Intraoperative Distal Esophageal (Core) Temperature | 35.87 °C | Standard Error 0.085 |
p-value: <0.000195% CI: [-0.139, 0.321]ANOVA