Trials / Completed
CompletedNCT02079311
Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia
Evaluation of Perioperative Core Body Temperature When Using Forced Air Warming or BARRIER® EasyWarm to Prevent Inadvertent Perioperative Hypothermia: An Open-label, Randomized Non-inferiority Comparison
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Molnlycke Health Care AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively. A non-inferiority, prospective, open-labelled, randomized, parallel investigation. Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia. The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups. A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Active self warming blanket | BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron. |
| DEVICE | Forced air warming device | Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2014-03-05
- Last updated
- 2015-11-13
- Results posted
- 2015-11-13
Locations
3 sites across 3 countries: Germany, Norway, United Kingdom
Source: ClinicalTrials.gov record NCT02079311. Inclusion in this directory is not an endorsement.