N/A
N=73
Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00815191 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Intraoperative Distal Esophageal (Core) Temperature — 35.96; 35.87 °C — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- a forced-air warming cover (Device); vital HEAT (vH2) Temperature Management System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Distal Esophageal (Core) Temperature |
35.96; 35.87 | <0.0001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00815191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.