NCT04709627

enFlow IV Fluid and Blood Warming System

Verification of Clinical Utility: enFlow IV Fluid and Blood Warming System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Vyaire Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hypothermia; Anesthesia

Interventions

Type	Name	Description
DEVICE	enFlow IV Fluid and Blood Warming System	The enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration.

Timeline

• Start date: 2021-07-06
• Primary completion: 2022-02-23
• Completion: 2022-02-23
• First posted: 2021-01-14
• Last updated: 2022-07-01

Locations

2 sites across 1 country: Finland

Regulatory

• FDA-regulated device study