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Clinical Trial Summary

This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an element of maintaining acceptable core temperatures.


Clinical Trial Description

Eligible subjects from the study will be recruited from patients with scheduled surgeries. After being informed about the study and potential risks, patients given informed consent will undergo scheduled surgery with the use of enFlow IV Fluid and Blood Warming System. The following temperature measurements will be collected during surgery: - Baseline temperature measurement (0-15 minutes prior to induction) - Induction temperature measurements (15 minutes, 30 minutes, 60 minutes, 90 minute post-induction) - Continued temperature measurements (every 30 minutes, plus end of surgery) - OR ambient temperature at induction and end of surgery. Temperature will be measured and collected post-surgery upon arrival to the PACU and 30 minutes post-arrival. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04709627
Study type Observational
Source Vyaire Medical
Contact
Status Completed
Phase
Start date July 6, 2021
Completion date February 23, 2022

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