Anesthesia Induced HypothermiaNCT01900067

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

A study testing BARRIER® EasyWarm Active Self-Warming Blanket in people with Anesthesia Induced Hypothermia and Inadvertent Perioperative Hypothermia, run by Molnlycke Health Care AB.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia
What is being tested?: BARRIER® EasyWarm Active Self-Warming Blanket
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 271 participants
Where: No sites listed yet
Study dates: Nov 2012to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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:
The subject's normal temperature regulation or
Perception of external temperature or

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Subcutaneous lipoatrophy
Medication: Current use of concomitant medications that present relevant risk to/of:
The subject's normal temperature regulation or
Perception of external temperature or Clinical Investigation Plan with Integrated Amendments 01 and 02, MD12-001, final, 14-Jan-2013 5(32)
Subcutaneous lipoatrophy or
All locoregional and neuroaxial blocks
Other:
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)
Known pregnancy

About this study

Official title: An Open-Label, Multicenter, Randomised, Controlled Study 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

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.

Conditions: Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia
Being tested: BARRIER® EasyWarm Active Self-Warming Blanket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BARRIER® EasyWarm Active Self-Warming BlanketDevice
Also called active warming

Study groups in NCT01900067
Study group	Role	What they receive
Active warming	Active comparator	BARRIER® EasyWarm Active Self-Warming Blanket Receives: Device: BARRIER® EasyWarm Active Self-Warming Blanket
Control	No intervention	no active warming, standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Mar 2013

First posted16 Jul 2013 (estimated)
Study startNov 2012
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anesthesia Induced HypothermiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01900067
Sponsor's protocol ID: MD12-001
Status last verified: Dec 2014
First submitted: 8 Jul 2013
Last updated: 6 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Randomised, Controlled Study 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
ClinicalTrials.gov ID: NCT01900067
Acronym / sponsor ID: MD12-001
Conditions: Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia
Study type: Interventional
Recruitment status: Completed
Enrolment: 271 participants (actual)
Lead sponsor: Molnlycke Health Care ABIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 16 Jul 2013 (estimated)
Results: Posted 6 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active warming	Active comparator	Device: BARRIER® EasyWarm Active Self-Warming BlanketBARRIER® EasyWarm Active Self-Warming Blanket
Control	No intervention	–no active warming, standard of care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (15 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BARRIER® EasyWarm Active Self-Warming BlanketAlso: active warming	Device	Active warming

Primary outcome

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
Time frame: temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.
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

Results and safety

Results posted to the registry on 6 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Warming	134	122
Control	137	124

Primary outcome: 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

Time frame: temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.. Mean (95% Confidence Interval). Unit: Degree Celsius (°C)

Measure	Active Warming n = 122	Control n = 124
Value	36.52 (36.15 to 36.89)	36.34 (36.0 to 36.74)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Warming	0 of 134 (0%)	23 of 134 (17.2%)	Not reported
Control	0 of 137 (0%)	0 of 137 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander Torossian, Prof principal investigator

University Hospital Giessen and Marburg

Johan Raeder, Prof principal investigator

OUS-Ullevål

Karin Geertsen, Dr principal investigator

Hallands sjukhus Varberg

Questions about this trial

What is this clinical trial studying?

A study testing BARRIER® EasyWarm Active Self-Warming Blanket in people with Anesthesia Induced Hypothermia and Inadvertent Perioperative Hypothermia, run by Molnlycke Health Care AB.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.