enFlow IV Fluid and Blood Warming System

Vyaire Medical50 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hypothermia; Anesthesia

Interventions

enFlow IV Fluid and Blood Warming SystemDEVICE

The enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Helsinki and Uusimaa Hospital District, Helsinki University Hospital

Helsinki, Finland

South Karelia Central Hospital (EKSOTE, ALTEK)

Lappeenranta, Finland

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

Core temperature for two periods

The mean of the measurements taken during the Induction period and during the Post-Induction period.

Time frame: 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).

Time frame: During 30 seconds made within 5 minutes of protocol time

Number of hyperthermic events

The incidence and duration of hyperthermic events (\>38.0 oC).

Time frame: 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

Time frame: Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.