enFlow IV Fluid and Blood Warming System

NCT04709627 | Completed FDA Device

• 2 other identifiers: 100-P009330000000064)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypothermia; Anesthesia

Keywords

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Core temperature for two periods

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

• Number of hypothermic events

  During 30 seconds made within 5 minutes of protocol time

• Number of hyperthermic events

  During 30 seconds made within 5 minutes of protocol time

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

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

Study Arms (1)

60 minute surgery

Patients completing at least 60 minutes of surgery

Device: enFlow IV Fluid and Blood Warming System

Interventions

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.

60 minute surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyaire Medical: lead
• Helsinki University Central Hospital: collaborator

Study Sites (2)

Helsinki and Uusimaa Hospital District, Helsinki University Hospital

Helsinki, 00029 HUS, Finland

Location

South Karelia Central Hospital (EKSOTE, ALTEK)

Lappeenranta, 53130, Finland

Location

Related Publications (4)

• Campbell G, Alderson P, Smith AF, Warttig S. Warming of intravenous and irrigation fluids for preventing inadvertent perioperative hypothermia. Cochrane Database Syst Rev. 2015 Apr 13;2015(4):CD009891. doi: 10.1002/14651858.CD009891.pub2.

  PMID: 25866139 BACKGROUND

• National Institute of Health and Care Excellence (NICE). Hypothermia: prevention and management in adults having surgery Clinical guideline. Original Published: 23 April 2008. nice.org.uk/guidance/cg65 2019

  BACKGROUND

• Pesonen E, Silvasti-Lundell M, Niemi TT, Kivisaari R, Hernesniemi J, Makinen MT. The focus of temperature monitoring with zero-heat-flux technology (3M Bair-Hugger): a clinical study with patients undergoing craniotomy. J Clin Monit Comput. 2019 Oct;33(5):917-923. doi: 10.1007/s10877-018-0227-z. Epub 2018 Nov 22.

  PMID: 30467673 BACKGROUND

• Makinen MT, Pesonen A, Jousela I, Paivarinta J, Poikajarvi S, Alback A, Salminen US, Pesonen E. Novel Zero-Heat-Flux Deep Body Temperature Measurement in Lower Extremity Vascular and Cardiac Surgery. J Cardiothorac Vasc Anesth. 2016 Aug;30(4):973-8. doi: 10.1053/j.jvca.2016.03.141. Epub 2016 Mar 22.

  PMID: 27521967 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 14, 2021
• Study Start: July 6, 2021
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)