enFlow IV Fluid and Blood Warming System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothermia; Anesthesia

Intervention / Treatment
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* Device: enFlow IV Fluid and Blood Warming System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Patients requiring surgery expected to last at least 1 hour. Expectation of the perioperative need for at least one liter of infused fluids warmed during infusion Informed Consent Exclusion Criteria: Recent history of fever (>38 C, within 24 hours of surgery) Active infection Pregnant women Terminal illness (<30 days) Intended use of cardiopulmonary bypass Clinical intention for perioperative cooling and hypothermia unavailability of esophageal measurement during surgery Attending physician does not believe participation of the patient is in their best interest.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 60 minute surgery<br>Patients completing at least 60 minutes of surgery | Device: enFlow IV Fluid and Blood Warming System<br>* The enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of intraoperative core temperature | Core temperature is defined as the highest temperature reading during 30 seconds made within 5 minutes of protocol time. The primary outcome measure will be the mean of the temperature measurements taken during the course of surgery | 15 and 30 minutes post-induction, then every 30 minutes untl the termination of the scheduled surgical procedure, and a final measurement recorded at the time of termination of the scheduled surgical procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature for two periods | The mean of the measurements taken during the Induction period and during the Post-Induction period. | Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery, | 
| Number of hypothermic events | The incidence and duration of hypothermic events (<36.0C). | During 30 seconds made within 5 minutes of protocol time | 
| Number of hyperthermic events | The incidence and duration of hyperthermic events (>38.0 oC). | During 30 seconds made within 5 minutes of protocol time | 
| Incidence of infusate outside acceptable operating range (i.e., device green range) | Device reading 35-42 oC | Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery