Patients having surgery with general anesthesia Surgery
Conditions
Interventions
Participants are randomized to four groups, each representing a different preoperative warming approach:
1. Conductive prewarming (CW) and conductive intraoperative warming i.e. CW+CW
2. Forced air (FAW) prewarming with forced air intraoperative warming i.e. FAW+FAW
3. No active prewarming (NAPW) with conductive intraoperative warming i.e. NAPW+CW
and
4. No active prewarming (NAPW) with forced air intraoperative warming i.e. NAPW+FAW.
Of note, all of these warming methods are well-established in practice and are achieved with commonly availabl
Sponsors
Cooper University HealthCare, Department of Anesthesiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects undergoing elective abdominal, gynecologic, breast surgery, plastic/reconstructive or urological surgery under general anesthesia 2. Surgery projected to last longer than 1.5 hours, but no longer than 4 hours
Exclusion criteria
Exclusion criteria: 1. Cardiac surgery 2. Vascular surgery 3. Pregnancy 4. Age < 18 years 5. Imprisonment 6. Inability to provide written informed consent 7. Inability to speak and/or read English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative hypothermia magnitude will be the primary outcome. Hypothermia will be defined as a core temperature <36 °C and quantified as the intraoperative area under the curve (AUC) < 36 °C (units °C*hr) detected with an esophageal temperature probe. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lowest temperature measured intraoperatively: degrees C, measured via esophageal temperature probe. Recorded in the electronic anesthesia record. 2. The percentage of the time of the case spent hypothermic: unit is minutes. Measured as the time in minutes under 36 degrees C divided by the duration of the operation (surgery) in minutes x 100. Times obtained from the electronic anesthesia record. 3. The absolute incidence of hypothermia: this is a binary score. I.e. if body temperature dropped below 36 degrees C at any point during the surgery, it was a yes. If not, then no. 4. The thermal comfort score: ordinal 5-point patient-reported Likert scale. Obtained by study coordinator at the end of the patient’s stay in the pre-operative area, i.e. just before transfer to the operating room. See attached PDF for the Likert scale questions. | — |
Countries
United States of America
Contacts
Public ContactRonak Desai
Outcome results
None listed