enFlow IV Fluid and Blood Warming System

June 28, 2022 updated by: Vyaire Medical

Verification of Clinical Utility: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029 HUS
        • Helsinki and Uusimaa Hospital District, Helsinki University Hospital
      • Lappeenranta, Finland, 53130
        • South Karelia Central Hospital (EKSOTE, ALTEK)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects from the study will be recruited from patients with scheduled surgeries. Most are expected to be inpatient due to the exclusion of short surgeries. For this study, only adults will be enrolled. Participation will also be limited to patients fluent in the language(s) of the information and consent form.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
60 minute surgery
Patients completing at least 60 minutes of surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,
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).
During 30 seconds made within 5 minutes of protocol time
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).
During 30 seconds made within 5 minutes of protocol time
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
Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vyaire Medical

Collaborators

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Mikko Lax, MD, Helsinki and Uusimaa Hospital District, Helsinki University Hospital
  • Principal Investigator: Seppo Mustola, MD, PhD, South Karelia Central Hospital (EKSOTE, ALTEK), Dept. of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2021

Primary Completion (Actual)

February 23, 2022

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-P0093
  • 30000000064) (Other Identifier: Vyaire Medical)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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