Complications, Hypothermia
Conditions
Brief summary
The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.
Detailed description
This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups. This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.
Interventions
DEVICEWarming Gown
Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.
OTHERStandard of care warming
The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery.
Sponsors
3M
Ascension Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects are adult patients 18 years and older elective surgery of \> 1 hour
Exclusion criteria
* Emergency and/or trauma cases * Patients with diminished mental capacity unable to fill out or respond to survey questions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypothermic Events | 12 hours | The primary outcome is the incidence of hypothermic events (core \<36 degrees celsius). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 12 hours | Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared. |
Countries
United States
Participant flow
Recruitment details
Inpatients having surgery between September 1, 2012 through April 9, 2013.
Pre-assignment details
Patients presenting with emergencies or with trauma were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 3M Bair Paws Flex Gown 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit
3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer | 46 |
| Control Standard of care, warm blankets
Standard of care - warm blankets | 48 |
| Total | 94 |
Baseline characteristics
| Characteristic | Control | Total | 3M Bair Paws Flex Gown |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 15.1 | 50.1 years STANDARD_DEVIATION 15 | 51.8 years STANDARD_DEVIATION 14.9 |
| BMI | 29.8 Kg/m^2 STANDARD_DEVIATION 7.1 | 31.2 Kg/m^2 STANDARD_DEVIATION 7.6 | 32.6 Kg/m^2 STANDARD_DEVIATION 7.9 |
| Pulse | 74.2 bpm STANDARD_DEVIATION 15.2 | 75.2 bpm STANDARD_DEVIATION 13.8 | 76.2 bpm STANDARD_DEVIATION 12.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 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 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 44 Participants | 85 Participants | 41 Participants |
| Region of Enrollment United States | 48 participants | 94 participants | 46 participants |
| Sex: Female, Male Female | 28 Participants | 65 Participants | 37 Participants |
| Sex: Female, Male Male | 20 Participants | 29 Participants | 9 Participants |
| Temperature | 36.5 Celsius STANDARD_DEVIATION 0.3 | 36.7 Celsius STANDARD_DEVIATION 0.4 | 36.8 Celsius STANDARD_DEVIATION 0.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 48 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 |
Outcome results
Primary
Incidence of Hypothermic Events
The primary outcome is the incidence of hypothermic events (core \<36 degrees celsius).
Time frame: 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3M Bair Paws Flex Gown | Incidence of Hypothermic Events | 5 participants |
| Control | Incidence of Hypothermic Events | 10 participants |
p-value: 0.12Chi-squared
Secondary
Patient Satisfaction
Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared.
Time frame: 12 hours
Population: All patients completed the patient anxiety and satisfaction survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3M Bair Paws Flex Gown | Patient Satisfaction | 59 change in percent satisfied |
| Control | Patient Satisfaction | 49 change in percent satisfied |
p-value: <0.05t-test, 2 sided