NCT02243462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

September 14, 2014

Last Update Submit

April 14, 2015

Conditions

Keywords

ShiveringHypothermiaPostoperativeTemperatureForced air warmer

Outcome Measures

Primary Outcomes (1)

  • inadvertent shivering post surgery

    number of patients who experience shivering in holding bay

    upto 2-3 hours post-surgery

Study Arms (2)

No pre-op warming

OTHER

No pre-warming in bay before surgery.

Other: No pre-op warming

Pre-op forced air warming

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: WarmTouch Convective Warming System, Forced air warmer (FAW)
Pre-op forced air warming

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

No pre-op warming

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any patient undergoing diagnostic laparoscopic surgery
  • Patients below age of 15 yrs
  • ASA 4 or higher patients
  • Patients not giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Indus Hospital

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Asghar, MBBS

    The Indus Hospital

    PRINCIPAL INVESTIGATOR
  • Shahid Amin

    The Indus Hospital

    STUDY DIRECTOR

Central Study Contacts

Asghar Ali, MBBS

CONTACT

Naila Baig-Ansari, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Anesthesia

Study Record Dates

First Submitted

September 14, 2014

First Posted

September 18, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations