Inadvertent Perioperative HypothermiaNCT02079311
Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia
A study testing Active self warming blanket and Forced air warming device in people with Inadvertent Perioperative Hypothermia and Preoperative Anxiety Experienced by the Patient, run by Molnlycke Health Care AB at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inadvertent Perioperative Hypothermia, Preoperative Anxiety Experienced by the Patient
- What is being tested?
- Active self warming blanket and Forced air warming device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2014to Apr 2014
- 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
- Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF)
- Male and female subjects aged 18 years and over
- Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes
- Scheduled surgery must be performed entirely under general anaesthesia
- The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area
- The subject must have an oral temperature measurement of at least 36.0°C when first measured in the preoperative setting
- The subject's scheduled surgical procedure must allow time to be warmed with a fully activated BARRIER® EasyWarm at least 30 minutes prior to induction of general anaesthesia
Who cannot join
- Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater
- Known Diabetes with an HbA1c of more than 6 %
- Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of:
- The subject's normal temperature regulation or
- Perception of external temperature or
- Subcutaneous lipoatrophy
Show all 16Show fewer
- Current use of concomitant medications that present relevant risk to/of:
- The subject's normal temperature regulation or
- Perception of external temperature or
- Subcutaneous lipoatrophy
- Epidural/Spinal anaesthesia
- An oral temperature measurement ≥ 37.5°
- Contraindications to the oesophagus temperature probe and oral thermometer
- Presence of skin and soft tissue disorders in areas covered directly by the device in the two treatment groups (e.g. pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat)
- Pregnancy
- Severe non-compliance to protocol as judged by the investigator and/or Mölnlycke Health Care
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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
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.
Read more
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.
- Being tested
- Active self warming blanket, Forced air warming device
- Keywords
- Patient warming, Active warming, Forced Air Warming, Warming blanket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active self warming blanketDevice
Also called BARRIER® EasyWarm
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.
Forced air warming deviceDevice
Also called Bair Hugger™, Equator® level 1.
Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
| Study group | Role | What they receive |
|---|---|---|
| Active self-warming blanket | Experimental | Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase Receives: Device: Active self warming blanket |
| Forced air warming device | Active comparator | Active warming with forced air warming (FAW) during the intraoperative phase. Receives: Device: Forced air warming device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in Core Body Temperature in the Two Treatment Groups.
Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.
Measured: Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
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 Inadvertent Perioperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Torossian, Prof. MD, Principal investigator, Universitätsklinikum Gießen und Marburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079311
- Sponsor's protocol ID
- MD13-001
- Status last verified
- Jun 2014
- First submitted
- 18 Feb 2014
- Last updated
- 13 Nov 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 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02079311
- Acronym / sponsor ID
- MD13-001
- Keywords
- Patient warming, Active warming, Forced Air Warming, Warming blanket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Posted 13 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active self-warming blanket | Experimental | Device: Active self warming blanketActive warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase |
| Forced air warming device | Active comparator | Device: Forced air warming deviceActive warming with forced air warming (FAW) during the intraoperative phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF)
- Male and female subjects aged 18 years and over
- Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes
- Scheduled surgery must be performed entirely under general anaesthesia
- The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area
Key exclusion criteria (16 listed)
- Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater
- Known Diabetes with an HbA1c of more than 6 %
- Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of:
- Current use of concomitant medications that present relevant risk to/of:
- Epidural/Spinal anaesthesia
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 |
|---|---|---|
| Active self warming blanketAlso: BARRIER® EasyWarmBARRIER® 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 | Active self-warming blanket |
| Forced air warming deviceAlso: Bair Hugger™, Equator® level 1.Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection. | Device | Forced air warming device |
Primary outcome
The Difference in Core Body Temperature in the Two Treatment Groups.
Time frame: Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.
Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Inadvertent Perioperative Hypothermia
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Not yet recruitingObservational study
The Clinical Decision-Making Skills of Operating Room Nurses Regarding Knowledge of Inadvertent Perioperative Hypothermia
THE EFFECT OF KNOWLEDGE LEVELS OF INADVERTET PERIOPERATIVE HYPOTHERMIA ON CLINICAL DECISION-MAKING SKILLS
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. MD principal investigator
Universitätsklinikum Gießen und Marburg GmbH
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active self warming blanket and Forced air warming device in people with Inadvertent Perioperative Hypothermia and Preoperative Anxiety Experienced by the Patient, run by Molnlycke Health Care AB at 3 sites in 3 countries.
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 7 inclusion and 16 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 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Norway, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 13 Nov 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 Core Body Temperature in the Two Treatment Groups. (time frame: Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2015.