Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active warming | Active Comparator | BARRIER® EasyWarm Active Self-Warming Blanket |
|
| Control | No Intervention | no active warming, standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BARRIER® EasyWarm Active Self-Warming Blanket | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group | The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period | temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention. |
Not provided
Not provided
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:
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:
Medication: Current use of concomitant medications that present relevant risk to/of:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Torossian, Prof | University Hospital Giessen and Marburg | Principal Investigator |
| Johan Raeder, Prof | OUS-Ullevål | Principal Investigator |
| Karin Geertsen, Dr | Hallands sjukhus Varberg | Principal Investigator |
| Bengt Horn af Åminne, Dr | Aleris Specialistvård, Motala | Principal Investigator |
| Elke Van Gerven, Dr | UZ Leuven Gasthuisberg | Principal Investigator |
| Marc Van de Velde, Prof. | UZ Leuven Gasthuisberg | Study Chair |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Warming | BARRIER® EasyWarm Active Self-Warming Blanket BARRIER® EasyWarm Active Self-Warming Blanket |
| FG001 | Control | no active warming, standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Warming | BARRIER® EasyWarm Active Self-Warming Blanket |
| BG001 | Control | no active warming, standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group | The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period | Posted | Mean | 95% Confidence Interval | Degree Celsius (°C) | temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Warming | BARRIER® EasyWarm Active Self-Warming Blanket |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness of skin | Skin and subcutaneous tissue disorders | All adverse device effects were of the type redness of skin under one or more of the warmers of the device. Once the device was removed the redness vanished quickly without further treatment. Redness was judged to be caused by local vasodilatation. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jenny Höglind | Mölnlycke Health Care AB, Surgical Division | 0046 31 722 30 00 | Jenny.Hoglind@molnlycke.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 134 |
| 23 |
| 134 |
| EG001 | Control | No active warming, standard of care | 0 | 137 | 0 | 137 |
|
The agreement state that sponsor is the owner of all results. The Investigator may perform a secondary publication from an individual investigation site without disclosing confidential information received from sponsor after the multi-center publication or within 12 months after termination of the investigation if no such multi-centre publication takes place.