Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia

Molnlycke Health Care

Status

Completed

Conditions

Anesthesia Induced Hypothermia

Inadvertent Perioperative Hypothermia

Treatments

Device: BARRIER® EasyWarm Active Self-Warming Blanket

Study type

Interventional

Funder types

Industry

Identifiers

NCT01900067

MD12-001

Details and patient eligibility

About

The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to Prevent General Anaesthesia Induced Hypothermia During the Perioperative Surgical Period. Null hypothesis (H0): There is no difference between the two study populations (interventional treatment group versus control treatment group) regarding the average of core body temperature measurements during the perioperative phase.Alternative hypothesis (H1): The average of core body temperature measurements during the perioperative phase is significantly higher in the interventional group compared to that of the control group.

Enrollment

271 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Gender: Both men and women are included into the study
Subjects' age: Subjects must be at least 18 years old to be included into the study
Type of anaesthesia: Only subjects receiving general anaesthesia are included into the study
Type of surgery: Subjects undergoing only the following three types of surgical procedures (i.e. inclusive of laparoscopic procedures) are included into the study:
- Gynaecological
- Orthopaedic
- Ear, nose and throat (ENT)
Length of surgery: Subjects scheduled for a surgery with a minimum length of 30 minutes and maximum length of 120 minutes
Temperature: Subjects should have a tympanic temperature measurement equal to or greater than 36.0 degrees Celsius when first measured in the preoperative setting the same day as the surgical procedure and before randomisation
Informed Consent Form (ICF): The subject must be able to understand and sign an ICF
Method of temperature assessment: The subject must be able to receive temperature assessments via a tympanic thermometer
Preoperative warming: Subject's scheduled surgical procedure must allow time to be warmed with a fully activated study Investigational Device (ID), at least 30 minutes prior to induction of general anaesthesia
Follow up: The subject must be able to complete a health outcomes questionnaire for follow up 24 hours (+/- 6 hours) after removal of the ID

Exclusion criteria

American Society of Anesthesiologists (ASA) Physical Status Classification rating: Subjects with a ASA rating of 4 or greater are excluded from the study
Comorbidity: Known Diabetes with an HbA1c of more than 6 %
Temperature: Subjects with a tympanic temperature measurement below 36.0 degrees Celsius taken in the preoperative setting
Medical history: Subject reports relevant medical history (e.g., neuropathy, peripheral vascular disease, or other) that presents risk to/of:
1. The subject's normal temperature regulation or
2. Perception of external temperature or
3. Subcutaneous lipoatrophy
Medication: Current use of concomitant medications that present relevant risk to/of:
1. The subject's normal temperature regulation or
2. Perception of external temperature or Clinical Investigation Plan with Integrated Amendments 01 and 02, MD12-001, final, 14-Jan-2013 5(32)
3. Subcutaneous lipoatrophy or
4. All locoregional and neuroaxial blocks
Other:
1. Presence of skin and soft tissue disorders in areas covered directly by the ID (e.g., pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat)
2. Known pregnancy