Carbon Polymer Blankets to Prevent Incidence Of Peri-Operative Hypothermia (IPH) in the DSU
Primary Purpose
Hypothermia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Carbon polymer warming blanket
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia
Eligibility Criteria
Inclusion Criteria:
- All patients, who are scheduled for non-emergency daycase surgery which will take place with them in the supine position
Exclusion Criteria:
- 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
Sites / Locations
- Brighton and Sussex University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Routine practice
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
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
Time in recovery
This will recorded by the recovery staff as entry time and discharge time from recovery.
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
Full Information
NCT ID
NCT01285206
First Posted
January 25, 2011
Last Updated
January 26, 2011
Sponsor
Brighton and Sussex University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01285206
Brief Title
Carbon Polymer Blankets to Prevent Incidence Of Peri-Operative Hypothermia (IPH) in the DSU
Official Title
A Study To Determine Whether Carbon Polymer Blankets Can Reduce The During And After Short, Day Operations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Brighton and Sussex University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine practice
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Carbon polymer warming blanket
Other Intervention Name(s)
HotDog warming blanket
Intervention Description
Routine practice ( + no carbon polymer blanket) versus use of HotDog carbon polymer warming blanket throughout day surgery procedure
Primary Outcome Measure Information:
Title
Core temperature
Description
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.
Time Frame
Every 15 minutes
Secondary Outcome Measure Information:
Title
Total blood loss
Description
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
Time Frame
At the end of the operative procedure
Title
Blood transfusion
Description
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
Time Frame
From the start of the operation until discharge. If patient is re-admitted within 24 hours requiring blood transfusion - also be counted
Title
Wound infection
Description
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.
Time Frame
Upon patient discharge/ At GP follow-up at one month
Title
Shivering (need for treatment or not)
Description
The occurrence of shivering (andneed for treatment or not) will be recorded by the recovery staff on the questionnaire sheets
Time Frame
Recorded during recovery stay
Title
Time in recovery
Description
This will recorded by the recovery staff as entry time and discharge time from recovery.
Time Frame
Recorded during recovery stay
Title
Time taken for patient to be considered fit for discharge i.e. length of hospital stay.
Description
This data will be taken from the patient's notes: operation date until date of (fit for) discharge from hospital
Time Frame
Upon discharge from hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients, who are scheduled for non-emergency daycase surgery which will take place with them in the supine position
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manu N Sharma, MBBS
Email
mpns@doctors.org.uk
First Name & Middle Initial & Last Name or Official Title & Degree
C. Mark Harper, MBBS
Email
mark.harper@doctors.org.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Mark Harper, MBBS
Organizational Affiliation
Brighton and Sussex University Hospitals NHS Trust
Official's Role
Study Director
Facility Information:
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
State/Province
East Sussex
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark C Harper, MBBS
12. IPD Sharing Statement
Links:
URL
http://www.hotdogwarming.com/
Description
HotDog Warming Blanket webpage link
Learn more about this trial
Carbon Polymer Blankets to Prevent Incidence Of Peri-Operative Hypothermia (IPH) in the DSU
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