Inadvertent Perioperative HypothermiaNCT01056991
Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket
A study testing warming mattress and warming blanket in people with Inadvertent Perioperative Hypothermia and Patient Warming, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inadvertent Perioperative Hypothermia, Patient Warming
- What is being tested?
- warming mattress and warming blanket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All patients undergoing elective (non emergency) surgery who will require intra-operative warming
- Patients whose surgery will be performed with them in the supine position
Who cannot join
- Abdominal aortic aneurysm repair
- All adults (over 18 years) who refuse,who are unable to fully understand the trial
- ALL laparoscopic surgeries
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Sussex County Hospital, BSUH NHS Trust
Brighton, BN2 5BE
About this study
Official title: A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia
This study will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery.
- Being tested
- warming mattress, warming blanket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warming mattressOther
Also called Inditherm electric carbon polymer warming mattress
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
warming blanketOther
Also called forced-air warming blanket, Bair hugger
| Study group | Role | What they receive |
|---|---|---|
| warming mattress | Experimental | Patient warmed with electric mattress Receives: Other: warming mattress |
| warming blanket | Active comparator | Forced air warming blanket Receives: Other: warming blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research.
Measured: 15minutes to 2 hours approximately postoperatively in recovery room
Secondary outcomes (2)
shivering
Measured: up to 2h post op (time in recovery)
Core temperature
Measured: From induction of anaesthesia to arrival in recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust
- Investigators
- Christopher M Harper, MBBS FRCA, Principal investigator, BSUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056991
- Sponsor's protocol ID
- 09/183/HAR
- Status last verified
- Jun 2014
- First submitted
- 25 Jan 2010
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
PubMed 26787794
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia
- ClinicalTrials.gov ID
- NCT01056991
- Acronym / sponsor ID
- 09/183/HAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warming mattress | Experimental | Other: warming mattressPatient warmed with electric mattress |
| warming blanket | Active comparator | Other: warming blanketForced air warming blanket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing elective (non emergency) surgery who will require intra-operative warming
- Patients whose surgery will be performed with them in the supine position
Key exclusion criteria (3 listed)
- Abdominal aortic aneurysm repair
- All adults (over 18 years) who refuse,who are unable to fully understand the trial
- ALL laparoscopic surgeries
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 |
|---|---|---|
| warming mattressAlso: Inditherm electric carbon polymer warming mattresscomparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia | Other | warming mattress |
| warming blanketAlso: forced-air warming blanket, Bair hugger | Other | warming blanket |
Primary outcome
Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research.
Time frame: 15minutes to 2 hours approximately postoperatively in recovery room
2 secondary outcomes
shivering
Time frame: up to 2h post op (time in recovery)
Core temperature
Time frame: From induction of anaesthesia to arrival in recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
- Derived from this study: PubMed 26787794John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
Related trials for Inadvertent Perioperative Hypothermia
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, 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.
Christopher M Harper, MBBS FRCA principal investigator
BSUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warming mattress and warming blanket in people with Inadvertent Perioperative Hypothermia and Patient Warming, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
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 2 inclusion and 3 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 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research. (time frame: 15minutes to 2 hours approximately postoperatively in recovery room). 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 NCT01056991, which also lists 1 linked publication.
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 12 Jun 2014.