enFlow IV Fluid and Blood Warming System

Hypothermia; Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709627
• Other study ID #: 100-P0093
• Secondary ID: 30000000064)
• Status: Completed
• Start date: July 6, 2021
• Est. completion date: February 23, 2022

Study information

• Verified date: June 2022
• Source: Vyaire Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki and Uusimaa Hospital District, Helsinki University Hospital	Helsinki
Finland	South Karelia Central Hospital (EKSOTE, ALTEK)	Lappeenranta

Sponsors (2)

Lead Sponsor	Collaborator
Vyaire Medical	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & 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;(4):CD009891. doi: 10.1002/14651858.CD009891.pub2. Review. — View Citation

Mäkinen MT, Pesonen A, Jousela I, Päivärinta J, Poikajärvi S, Albäck 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. — View Citation

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

Pesonen E, Silvasti-Lundell M, Niemi TT, Kivisaari R, Hernesniemi J, Mäkinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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,
Secondary	Number of hypothermic events	The incidence and duration of hypothermic events (<36.0C).	During 30 seconds made within 5 minutes of protocol time
Secondary	Number of hyperthermic events	The incidence and duration of hyperthermic events (>38.0 oC).	During 30 seconds made within 5 minutes of protocol time
Secondary	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,