Preoperative Warming and Perioperative Shivering

Not Applicable

• Conditions: Forced Air Warming Effect on Hypothermia
• Interventions: Device: Forced Air Warmer; Other: No pre-op warming

• Registration Number: NCT02243462
• Lead Sponsor: Indus Hospital and Health Network

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-14
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-18
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-op forced air warming	Forced Air Warmer	A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery
No pre-op warming	No pre-op warming	No pre-warming in bay before surgery.

Primary Outcome Measures

Name	Time	Method
inadvertent shivering post surgery	upto 2-3 hours post-surgery	number of patients who experience shivering in holding bay

Trial Locations

Locations (1)

The Indus Hospital; 🇵🇰 Karachi, Sind, Pakistan