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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03429205
Other study ID # 4578-17-SMC
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 15, 2018
Est. completion date November 21, 2022

Study information

Verified date April 2023
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump. The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered. The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last <2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date November 21, 2022
Est. primary completion date November 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Eligible for bariatric surgery - Surgery time estimated to be < 2 hours Exclusion Criteria: - Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies). - Surgery time estimated to be more than 2 hours

Study Design


Intervention

Other:
No external heating used during surgery
Deviation from external heating for all surgery standard
External heating blanket used during surgery
Standard external heating plan used in all surgery types

Locations

Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative core-temperature decline Core-temperature will be continuously measured throughout surgery Surgery duration, up to 2 hours from surgery start-time
Primary Arrival temperature at post anesthesia care unit (PACU) Core temperature upon arrival to recovery room arrival to recovery room, up to 2 h from surgery start-time
Secondary Hypothermia events Measurement of core temperature <35 C 3 hours from surgery start-time
Secondary Intraoperative blood loss Intraoperative bleeding score will be used Surgery duration, up to 2 hours from surgery start-time
Secondary Post operative complications Complications after surgery (30 days), graded according to Clavien-Dindo classification 30 days postoperatively
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