Preoperative Warming and Perioperative Shivering | NCT02243462

Studies
Preoperative Warming and Perioperative Shivering

NCT02243462

Sponsor

Indus Hospital and Health Network

Status

Unknown status

Last Update Posted

Apr 15, 2015Estimated

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Forced Air Warming Effect on Hypothermia

Interventions

Forced Air Warmer
No pre-op warming

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRD_IRB_2014_06_003	Other Identifier	IRD IRB

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Sep 14, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2015

Last Update Posted Date

Apr 15, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ali Asgher, Resident, Anesthesia, Indus Hospital and Health NetworkPrincipal Investigator

Lead Sponsor

Indus Hospital and Health NetworkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Forced Air Warmer	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Asghar Ali, MBBS	Contact			aliasgherkika@gmail.com
Naila Baig-Ansari, PhD	Contact			naila.baig.ansari@gmail.com

Overall Officials

Name	Affiliation	Role
Ali Asghar, MBBS	The Indus Hospital	Principal Investigator
Shahid Amin	The Indus Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Indus Hospital	Recruiting	Karachi	Sindh		Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D007035	Hypothermia

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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