Preoperative Warming and Perioperative Shivering (PWPS)
Primary Purpose
Forced Air Warming Effect on Hypothermia
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Forced Air Warmer
No pre-op warming
Sponsored by
About this trial
This is an interventional prevention trial for Forced Air Warming Effect on Hypothermia focused on measuring Shivering, Hypothermia, Postoperative, Temperature, Forced air warmer
Eligibility Criteria
Inclusion Criteria:
- All patients going under therapeutic laparoscopic surgery
- All patients between 15-70 years irrespective of their gender
- ASA 1-3 patients
- Those who have given informed consent
Exclusion Criteria:
- Any patient undergoing diagnostic laparoscopic surgery
- Patients below age of 15 yrs
- ASA 4 or higher patients
- Patients not giving informed consent
Sites / Locations
- The Indus HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
No pre-op warming
Pre-op forced air warming
Arm Description
No pre-warming in bay before surgery.
A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery
Outcomes
Primary Outcome Measures
inadvertent shivering post surgery
number of patients who experience shivering in holding bay
Secondary Outcome Measures
Full Information
NCT ID
NCT02243462
First Posted
September 14, 2014
Last Updated
April 14, 2015
Sponsor
Indus Hospital and Health Network
1. Study Identification
Unique Protocol Identification Number
NCT02243462
Brief Title
Preoperative Warming and Perioperative Shivering
Acronym
PWPS
Official Title
Effectiveness of Pre-operative Warming in Prevention of Peri-operative Shivering
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indus Hospital and Health Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shivering is one of the most commonly recognized problem associated with anesthesia, It is believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.
Forced air warmers are the most frequently used active warming devices in the peri-operative setting. Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.
Detailed Description
Inadvertent peri-operative hypothermia (IPH) and shivering is one of the most commonly recognized problem during anesthesia which is believed to be thermoregulatory in origin. Although shivering is uncomfortable for most patients, it is unlikely that this relatively small increase in total body oxygen consumption in the average shivering patient is associated with increased peri-operative morbidity. It is common for patients to complain that their worst memory from the recovery room is the intense cold sensation and uncontrollable shivering. New guidelines recommend that patients core temperature has to be maintained at >36°C, postoperatively. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.
Forced air warmers are the most frequently used active warming devices in the peri-operative setting. They are effective at preventing hypothermia induced shivering when used before induction of anesthesia, during anesthesia and surgery, and after emergence in the post-anesthesia care unit. Other methods such as warm fluids, opioids, blankets and warm light devices can be used but are less effective as compared to the forced air warming devices.
Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forced Air Warming Effect on Hypothermia
Keywords
Shivering, Hypothermia, Postoperative, Temperature, Forced air warmer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No pre-op warming
Arm Type
Other
Arm Description
No pre-warming in bay before surgery.
Arm Title
Pre-op forced air warming
Arm Type
Active Comparator
Arm Description
A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery
Intervention Type
Device
Intervention Name(s)
Forced Air Warmer
Other Intervention Name(s)
WarmTouch Convective Warming System, Forced air warmer (FAW)
Intervention Description
A forced air warmer device will be used to pre-warm patients for 10 minutes in holding bay before surgery. Air warming device is an electrically powered control unit, hose, and inflatable "blanket". The control unit has an air filter and heater, which warms air entrained from the environment. The hose connects to a blanket.
Intervention Type
Other
Intervention Name(s)
No pre-op warming
Intervention Description
No forced air warming of the patient prior to being taken in for surgery
Primary Outcome Measure Information:
Title
inadvertent shivering post surgery
Description
number of patients who experience shivering in holding bay
Time Frame
upto 2-3 hours post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients going under therapeutic laparoscopic surgery
All patients between 15-70 years irrespective of their gender
ASA 1-3 patients
Those who have given informed consent
Exclusion Criteria:
Any patient undergoing diagnostic laparoscopic surgery
Patients below age of 15 yrs
ASA 4 or higher patients
Patients not giving informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asghar Ali, MBBS
Email
aliasgherkika@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naila Baig-Ansari, PhD
Email
naila.baig.ansari@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Asghar, MBBS
Organizational Affiliation
The Indus Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahid Amin
Organizational Affiliation
The Indus Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Indus Hospital
City
Karachi
State/Province
Sind
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naila Baig-Ansari, PhD
Email
naila.baig.ansari@gmail.com
First Name & Middle Initial & Last Name & Degree
Rashna Dubash
Email
rashna.dubash@irdresearch.org
First Name & Middle Initial & Last Name & Degree
Ali Asghar, MBBS
First Name & Middle Initial & Last Name & Degree
Shahid Amin, MBBS
12. IPD Sharing Statement
Learn more about this trial
Preoperative Warming and Perioperative Shivering
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