Preoperative Warming and Perioperative Shivering (PWPS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Forced Air Warming Effect on Hypothermia
• Intervention / Treatment: Other: No pre-op warming; Device: Forced Air Warmer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asghar Ali, MBBS; Email: aliasgherkika@gmail.com

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan
      • Recruiting
      • The Indus Hospital
      • Contact: Rashna Dubash; Email: rashna.dubash@irdresearch.org
      • Principal Investigator: Ali Asghar, MBBS
      • Sub-Investigator: Shahid Amin, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: No pre-op warming; No pre-warming in bay before surgery.	Other: No pre-op warming; No forced air warming of the patient prior to being taken in for surgery
ACTIVE_COMPARATOR: Pre-op forced air warming; A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery	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 Names: WarmTouch Convective Warming System; Forced air warmer (FAW)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inadvertent shivering post surgery	number of patients who experience shivering in holding bay	upto 2-3 hours post-surgery

Collaborators and Investigators

• Sponsor: Indus Hospital and Health Network
• Investigators: Principal Investigator: Ali Asghar, MBBS, The Indus Hospital; Study Director: Shahid Amin, The Indus Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ANTICIPATED): July 1, 2015
• Study Completion (ANTICIPATED): July 1, 2015

Study Registration Dates

• First Submitted: September 14, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (ESTIMATE): September 18, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Temperature; Hypothermia; Postoperative; Shivering; Forced air warmer
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: TIH-Anesth-001; IRD_IRB_2014_06_003 (OTHER: IRD IRB)