Preoperative Warming and Perioperative Shivering

NCT ID: NCT02243462

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Forced Air Warming Effect on Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No pre-op warming

No pre-warming in bay before surgery.

Group Type OTHER

No pre-op warming

Intervention Type OTHER

No forced air warming of the patient prior to being taken in for surgery

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

Group Type ACTIVE_COMPARATOR

Forced Air Warmer

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

No pre-op warming

No forced air warming of the patient prior to being taken in for surgery

Intervention Type OTHER

Other Intervention Names

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WarmTouch Convective Warming System Forced air warmer (FAW)

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indus Hospital and Health Network

OTHER

Sponsor Role lead

Responsible Party

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Ali Asgher

Resident, Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Asghar, MBBS

Role: PRINCIPAL_INVESTIGATOR

The Indus Hospital

Shahid Amin

Role: STUDY_DIRECTOR

The Indus Hospital

Locations

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The Indus Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Asghar Ali, MBBS

Role: CONTACT

Naila Baig-Ansari, PhD

Role: CONTACT

Facility Contacts

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Naila Baig-Ansari, PhD

Role: primary

Rashna Dubash

Role: backup

Other Identifiers

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IRD_IRB_2014_06_003

Identifier Type: OTHER

Identifier Source: secondary_id

TIH-Anesth-001

Identifier Type: -

Identifier Source: org_study_id

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