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Completed

NCT Number: NCT04709627

enFlow IV Fluid and Blood Warming System

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.

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Key information

Conditions

Hypothermia; Anesthesia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki and Uusimaa Hospital District, Helsinki University Hospital, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

enFlow IV Fluid and Blood Warming System

Device

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

Primary outcomes

  1. Maintenance of intraoperative core temperature

    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.

    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

Secondary outcomes

  1. Core temperature for two periods

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

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

  2. Number of hypothermic events

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

    The incidence and duration of hypothermic events (<36.0C).

  3. Number of hyperthermic events

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

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

  4. Incidence of infusate outside acceptable operating range (i.e., device "green range")

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

    Device reading 35-42 oC

Sponsors and collaborators

Lead sponsor

Vyaire Medical

Industry

Collaborators

  • Helsinki University Central Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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