Clinical study assessing the safety and efficacy of BARRIER EasyWarm
A clinical study to assess the safety and efficacy of BARRIER® EasyWarm®, an active self-warming blanket, shows that the use of this blanket helps to prevent hypothermia1.
- With the active self-warming blanket, intraoperative temperature was maintained at a stable level for 2.5 hours.
- The typical temperature drop of 1–1.5°C on induction of anaesthesia did not occur in patients. A temperature drop of only 0.6°C was recorded.
- No serious adverse events were reported.
- The active self-warming blanket was well-received in terms of comfort and warmth by the patients.
The study was performed in 2011 at the University General Hospital, in Houston, Texas and at the Physicians’ Surgical Care Center in Winter Park, Orlando, Florida, both in the United States.
One-hundred twelve (112) patients were enrolled and evaluated for safety and 68 were valid for protocol efficacy analysis.
The patients were scheduled to undergo general anaesthesia during a surgical procedure scheduled for a minimum of 60 minutes and maximum of 180 minutes. The schedule had to allow the subjects to be prewarmed with a fully activated blanket for at least 30 minutes prior to anaesthesia.
The typical temperature drop of 1-1.5°C on induction of anaesthesia did not happen. A drop of only 0.6°C was recorded in this trial. It was concluded that temperature was maintained at a stable level for 2.5 hours during the period of surgery1.
Download the clinical summary (PDF)