Status:
COMPLETED
enFlow IV Fluid and Blood Warming System
Lead Sponsor:
Vyaire Medical
Collaborating Sponsors:
Helsinki University Central Hospital
Conditions:
Hypothermia; Anesthesia
Eligibility:
All Genders
18+ years
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 perform...
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 schedu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04709627
Start Date
July 6 2021
End Date
February 23 2022
Last Update
July 1 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Helsinki and Uusimaa Hospital District, Helsinki University Hospital
Helsinki, Finland, 00029 HUS
2
South Karelia Central Hospital (EKSOTE, ALTEK)
Lappeenranta, Finland, 53130