Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket

Inadvertent Perioperative Hypothermia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056991
• Other study ID #: 09/183/HAR
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: June 11, 2014
• Start date: February 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2014
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Abdominal aortic aneurysm repair

• All adults (over 18 years) who refuse,who are unable to fully understand the trial

• ALL laparoscopic surgeries

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Inadvertent Perioperative Hypothermia
• Patient Warming

Intervention

Other:
• warming mattress
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
• warming blanket

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital, BSUH NHS Trust	Brighton

Sponsors (1)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		15minutes to 2 hours approximately postoperatively in recovery room	No
Secondary	shivering		up to 2h post op (time in recovery)	No
Secondary	Core temperature		From induction of anaesthesia to arrival in recovery	No