Warming Systems During Surgery
Conditions
Keywords
heated blanket, heated pad
Brief summary
Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia. Secondary hypotheses include that: 1. intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming 2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming 3. final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.
Interventions
DEVICEheated blanket
heated blanket
DEVICEheated pad
patients will be warmed with a heated pad during surgery.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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 * Supine position (with or without lithotomy)
Exclusion criteria
* Pre-operative fever * Serious skin lesions * And contraindication to either PerfecTemp or forced-air warming
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Average Core Temperature | from tracheal intubation to 3 hours after or tracheal extubation | Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Temperatures Above 36 Degree | at the end of surgery | Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bair Hugger Heated Blanket Patients will be warmed during surgery with the Bair Hugger heated blanket.
heated blanket: heated blanket | 34 |
| LMA PerfecTemp System Patients will be warmed during surgery with the PerfecTemp heated pad .
heated pad: patients will be warmed with a heated pad during surgery. | 36 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 4 |
Baseline characteristics
| Characteristic | Bair Hugger Heated Blanket | LMA PerfecTemp System | Total |
|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 13 | 51 years STANDARD_DEVIATION 15 | 51 years STANDARD_DEVIATION 14 |
| preoperative oral temperature | 36.2 degrees C STANDARD_DEVIATION 0.9 | 36.8 degrees C STANDARD_DEVIATION 0.8 | 36.2 degrees C STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized Caucasian | 34 participants | 34 participants | 68 participants |
| Race/Ethnicity, Customized Not Caucasian | 0 participants | 2 participants | 2 participants |
| Region of Enrollment Canada | 11 participants | 13 participants | 24 participants |
| Region of Enrollment United States | 23 participants | 23 participants | 46 participants |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 36 |
| serious Total, serious adverse events | 0 / 34 | 0 / 36 |
Outcome results
Primary
Time Weighted Average Core Temperature
Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation
Time frame: from tracheal intubation to 3 hours after or tracheal extubation
Population: Randomized patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bair Hugger Heated Blanket | Time Weighted Average Core Temperature | 36.11 Degrees C | Standard Deviation 0.5 |
| LMA PerfecTemp System | Time Weighted Average Core Temperature | 36.02 Degrees C | Standard Deviation 0.55 |
Secondary
Proportion of Patients With Temperatures Above 36 Degree
Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery
Time frame: at the end of surgery
Population: Enrolled patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bair Hugger Heated Blanket | Proportion of Patients With Temperatures Above 36 Degree | 30 Participants |
| LMA PerfecTemp System | Proportion of Patients With Temperatures Above 36 Degree | 21 Participants |
p-value: 0.0069Regression, Logistic