Carbon Polymer Blankets to Prevent Incidence Of Peri-Operative Hypothermia (IPH) in the DSU
A Study To Determine Whether Carbon Polymer Blankets Can Reduce The During And After Short, Day Operations
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJanuary 27, 2011
September 1, 2010
3 months
January 25, 2011
January 26, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Every 15 minutes
Secondary Outcomes (6)
Total blood loss
At the end of the operative procedure
Blood transfusion
From the start of the operation until discharge. If patient is re-admitted within 24 hours requiring blood transfusion - also be counted
Wound infection
Upon patient discharge/ At GP follow-up at one month
Shivering (need for treatment or not)
Recorded during recovery stay
Time in recovery
Recorded during recovery stay
- +1 more secondary outcomes
Study Arms (1)
Routine practice
EXPERIMENTALInterventions
Routine practice ( + no carbon polymer blanket) versus use of HotDog carbon polymer warming blanket throughout day surgery procedure
Eligibility Criteria
You may qualify if:
- All patients, who are scheduled for non-emergency daycase surgery which will take place with them in the supine position
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
C. Mark Harper, MBBS
Brighton and Sussex University Hospitals NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 27, 2011
Study Start
December 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
January 27, 2011
Record last verified: 2010-09