Preoperative Warming and Perioperative Shivering

Forced Air Warming Effect on Hypothermia Clinical Trial

— PWPS  

Official title:

Effectiveness of Pre-operative Warming in Prevention of Peri-operative Shivering

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243462
• Other study ID #: TIH-Anesth-001
• Secondary ID: IRD_IRB_2014_06_
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2014
• Last updated: April 14, 2015
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2015
• Source: Indus Hospital
• Contact: Asghar Ali, MBBS
• Email: aliasgherkika[@]gmail.com
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Forced Air Warming Effect on Hypothermia
• Hypothermia

Intervention

Device:
• Forced Air Warmer
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.

Other:
• No pre-op warming
No forced air warming of the patient prior to being taken in for surgery

Locations

Country	Name	City	State
Pakistan	The Indus Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Indus Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inadvertent shivering post surgery	number of patients who experience shivering in holding bay	upto 2-3 hours post-surgery	No