HypothermiaNCT01285206
Carbon Polymer Blankets to Prevent Incidence Of Peri-Operative Hypothermia (IPH) in the DSU
A study testing Carbon polymer warming blanket in people with Hypothermia, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients whose temperature drops below 36.0 degrees Centigrade during or after surgery suffer more complications, such as wound infections and increased blood loss, resulting in more blood transfusions and longer hospital stays than those who don't. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Carbon polymer warming blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Mar 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients, who are scheduled for non-emergency daycase surgery which will take place with them in the supine position
Who cannot join
- Those patients who refuse
- Who are unable to fully understand the trial and give valid
- Informed consent; OR
- Who will not be positioned supine on the operating table
Trial locations and contacts
1 site in 1 country.
Manu N Sharma, MBBS contact
C. Mark Harper, MBBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex
Mark C Harper, MBBS
About this study
Official title: A Study To Determine Whether Carbon Polymer Blankets Can Reduce The During And After Short, Day Operations
Patients whose temperature drops below 36.0 degrees Centigrade during or after surgery suffer more complications, such as wound infections and increased blood loss, resulting in more blood transfusions and longer hospital stays than those who don't.
There is evidence that even a drop below 36.5 degrees Centigrade is sufficient to cause significant adverse effects. Although there is much evidence regarding the effectiveness of warming for long operations, there is nothing looking at short procedures such as those undertaken in the daysurgery setting.
A new carbon polymer blanket (HotDog Augustine Biomedical and Design) has been shown, in volunteer studies, to be as effective as forced air warming blankets (which are used for long operations) in preventing hypothermia. In contrast to forced air, the carbon polymer is reusable and has lower running-costs so is likely to be cheaper in the long term. This is particularly relevant in the day surgery setting where high numbers of patients are operated on. Additionally, and unlike the forced air warmers, the blanket can run on a battery so it can be applied from the moment the patient goes to sleep to the moment they wake up so it could actually prove more effective at preventing hypothermia in the clinical setting. This study aims to determine whether the carbon polymer blankets can reduce the incidence of hypothermia in the day surgery (ie. short operating time) setting.
Read the detailed description
Recently published NICE guidelines recommend using fluid warmers for all infusions of 500mls or more and forced-air warming blankets for all main theatre operations. These guidelines have been extrapolated from work done on longer operations.
Patients whose temperature drops below 36 degrees Centigrade during or after surgery suffer more complications and blood loss than those whose temperature remains above 36 degrees Centigrade. They also often require more blood transfusions and stay in hospital for longer. Some of these complications are more common even when the temperature drops below 36.5.
Disposable forced-air warming blankets prevent hypothermia, but cannot be re-used and therefore incur a significant expense in terms of consumables.
Re-usable carbon polymer blankets, such as the HotDog, have been shown to not only be effective in preventing hypothermia, but have also been shown to maintain core temperature as effectively as forced air blankets.
Carbon polymer blankets are re-usable, with the added associated benefit of lower running costs. Therefore, in the face of limited NHS resources a reusable money saving alternative, such as the carbon polymer HotDog, would be a preferred option to the disposable forced air blanket.
The current data on the effectiveness of the carbon polymer blanket is from volunteers. This study is actually powered to show a reduction in the number of patients who get cold in a clinical setting.
References:
NICE. Perioperative hypothermia (inadvertent): the management of inadvertent peri-operative hypothermia in adults.NICE Clinical Guideline 29. London: National Institute for Health and Clinical Excellence, 2008. http://www.nice.org.uk/GC065.
Schmeid H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. The Lancet 1996; 347:289-92.
Rajagopalan S, Mascha E, Na J, Sessler DI: The Effects of Mild Perioperative Hypothermia on Blood Loss and Transfusion Requirement. Anesthesiology 2008;108:717.
- Conditions
- Hypothermia
- Being tested
- Carbon polymer warming blanket
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon polymer warming blanketDevice
Also called HotDog warming blanket
Routine practice ( + no carbon polymer blanket) versus use of HotDog carbon polymer warming blanket throughout day surgery procedure
| Study group | Role | What they receive |
|---|---|---|
| Routine practice | Experimental | Not described Receives: Device: Carbon polymer warming blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
Temperatures will be taken:
Preoperatively on the day case unit ward, At the beginning of the operation Every 15 minutes thereafter intraoperatively. At the end of the operation in recovery Every 30 minutes until discharged home.
Measured: Every 15 minutes
Secondary outcomes (6)
Total blood loss
Total blood loss will be recorded by surgical team. Blood collected in suction cannister and estimated blood loss from surgical swab wet vs. dry weight
Measured: At the end of the operative procedure
Blood transfusion
Whether a blood transfusion has taken place as a direct consequence of the operation will be recorded in the patients notes. The type and amount of blood products given will also be recorded in the patients notes and by the hospital blood bank services
Measured: From the start of the operation until discharge. If patient is re-admitted within 24 hours requiring blood transfusion - also be counted
Wound infection
The development of a wound infection will either be recorded in the patient's notes if associated with the patient's hospital stay, or the information will be obtained from the GP follow-up phone-call.
Measured: Upon patient discharge/ At GP follow-up at one month
Shivering (need for treatment or not)
The occurrence of shivering (andneed for treatment or not) will be recorded by the recovery staff on the questionnaire sheets
Measured: Recorded during recovery stay
Time in recovery
This will recorded by the recovery staff as entry time and discharge time from recovery.
Measured: Recorded during recovery stay
Time taken for patient to be considered fit for discharge i.e. length of hospital stay.
This data will be taken from the patient's notes: operation date until date of (fit for) discharge from hospital
Measured: Upon discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- C. Mark Harper, MBBS, Study director, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285206
- Sponsor's protocol ID
- 10/H1107/5
- Status last verified
- Sep 2010
- First submitted
- 25 Jan 2011
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Determine Whether Carbon Polymer Blankets Can Reduce The During And After Short, Day Operations
- ClinicalTrials.gov ID
- NCT01285206
- Acronym / sponsor ID
- 10/H1107/5
- Conditions
- Hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 27 Jan 2011 (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.
Patients whose temperature drops below 36.0 degrees Centigrade during or after surgery suffer more complications, such as wound infections and increased blood loss, resulting in more blood transfusions and longer hospital stays than those who don't.
There is evidence that even a drop below 36.5 degrees Centigrade is sufficient to cause significant adverse effects. Although there is much evidence regarding the effectiveness of warming for long operations, there is nothing looking at short procedures such as those undertaken in the daysurgery setting.
A new carbon polymer blanket (HotDog Augustine Biomedical and Design) has been shown, in volunteer studies, to be as effective as forced air warming blankets (which are used for long operations) in preventing hypothermia. In contrast to forced air, the carbon polymer is reusable and has lower running-costs so is likely to be cheaper in the long term. This is particularly relevant in the day surgery setting where high numbers of patients are operated on. Additionally, and unlike the forced air warmers, the blanket can run on a battery so it can be applied from the moment the patient goes to sleep to the moment they wake up so it could actually prove more effective at preventing hypothermia in the clinical setting. This study aims to determine whether the carbon polymer blankets can reduce the incidence of hypothermia in the day surgery (ie. short operating time) setting.
Detailed description
Recently published NICE guidelines recommend using fluid warmers for all infusions of 500mls or more and forced-air warming blankets for all main theatre operations. These guidelines have been extrapolated from work done on longer operations.
Patients whose temperature drops below 36 degrees Centigrade during or after surgery suffer more complications and blood loss than those whose temperature remains above 36 degrees Centigrade. They also often require more blood transfusions and stay in hospital for longer. Some of these complications are more common even when the temperature drops below 36.5.
Disposable forced-air warming blankets prevent hypothermia, but cannot be re-used and therefore incur a significant expense in terms of consumables.
Re-usable carbon polymer blankets, such as the HotDog, have been shown to not only be effective in preventing hypothermia, but have also been shown to maintain core temperature as effectively as forced air blankets.
Carbon polymer blankets are re-usable, with the added associated benefit of lower running costs. Therefore, in the face of limited NHS resources a reusable money saving alternative, such as the carbon polymer HotDog, would be a preferred option to the disposable forced air blanket.
The current data on the effectiveness of the carbon polymer blanket is from volunteers. This study is actually powered to show a reduction in the number of patients who get cold in a clinical setting.
References:
NICE. Perioperative hypothermia (inadvertent): the management of inadvertent peri-operative hypothermia in adults.NICE Clinical Guideline 29. London: National Institute for Health and Clinical Excellence, 2008. http://www.nice.org.uk/GC065.
Schmeid H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. The Lancet 1996; 347:289-92.
Rajagopalan S, Mascha E, Na J, Sessler DI: The Effects of Mild Perioperative Hypothermia on Blood Loss and Transfusion Requirement. Anesthesiology 2008;108:717.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine practice | Experimental | Device: Carbon polymer warming blanket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients, who are scheduled for non-emergency daycase surgery which will take place with them in the supine position
Key exclusion criteria (4 listed)
- Those patients who refuse
- Who are unable to fully understand the trial and give valid
- Informed consent; OR
- Who will not be positioned supine on the operating table
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 |
|---|---|---|
| Carbon polymer warming blanketAlso: HotDog warming blanketRoutine practice ( + no carbon polymer blanket) versus use of HotDog carbon polymer warming blanket throughout day surgery procedure | Device | Routine practice |
Primary outcome
Core temperature
Time frame: Every 15 minutes
Temperatures will be taken: Preoperatively on the day case unit ward, At the beginning of the operation Every 15 minutes thereafter intraoperatively. At the end of the operation in recovery Every 30 minutes until discharged home.
6 secondary outcomes
Total blood loss
Time frame: At the end of the operative procedure
Blood transfusion
Time frame: From the start of the operation until discharge. If patient is re-admitted within 24 hours requiring blood transfusion - also be counted
Wound infection
Time frame: Upon patient discharge/ At GP follow-up at one month
Shivering (need for treatment or not)
Time frame: Recorded during recovery stay
Time in recovery
Time frame: Recorded during recovery stay
Time taken for patient to be considered fit for discharge i.e. length of hospital stay.
Time frame: Upon discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
- HotDog Warming Blanket webpage linkLink provided by the sponsor.
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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.
Manu N Sharma, MBBS contact
C. Mark Harper, MBBS contact
C. Mark Harper, MBBS study director
Brighton and Sussex University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon polymer warming blanket in people with Hypothermia, 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jan 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manu N Sharma, MBBS (mpns@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (time frame: Every 15 minutes). 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 27 Jan 2011.