Clinical trial NCT04709627: enFlow IV Fluid and Blood Warming System
Official title: Verification of Clinical Utility: enFlow IV Fluid and Blood Warming System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia; Anesthesia
Keywords: Surgery
Lead sponsor: Vyaire Medical
Sponsor class: INDUSTRY
Collaborators: name: Helsinki University Central Hospital
First posted: 2021-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maintenance of intraoperative core temperature
timeFrame: 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:
measure: Core temperature for two periods
timeFrame: Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,
measure: Number of hypothermic events
timeFrame: During 30 seconds made within 5 minutes of protocol time
measure: Number of hyperthermic events
timeFrame: During 30 seconds made within 5 minutes of protocol time
measure: Incidence of infusate outside acceptable operating range (i.e., device "green range")
timeFrame: Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki and Uusimaa Hospital District, Helsinki University Hospital
city: Lappeenranta
country: Finland
facility: South Karelia Central Hospital (EKSOTE, ALTEK)
Study officials:
affiliation: Helsinki and Uusimaa Hospital District, Helsinki University Hospital
name: Mikko Lax, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Karelia Central Hospital (EKSOTE, ALTEK), Dept. of Anesthesiology
name: Seppo Mustola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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
citation: 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.
citation: 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.