enFlow IV Fluid and Blood Warming System

Vyaire Medical

Status: Completed

Conditions: Hypothermia; Anesthesia

Treatments: Device: enFlow IV Fluid and Blood Warming System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04709627

30000000064) (Other Identifier)

100-P0093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

60 minute surgery

Description:

Patients completing at least 60 minutes of surgery

Treatment:

Device: enFlow IV Fluid and Blood Warming System