Survival Thermal Blanket Versus Draping Fabric to Prevent Hypothermia in Geriatric Surgical Patients

July 30, 2021 updated by: Aida Rosita Tantri, Indonesia University

Comparison Effect of Using Between Survival Thermal Blanket and Draping Fabric as Substitute for Perforated Blanket With Forced Air Warmer Usage as Perioperative Warmer : Study on Inadvertent Perioperative Hypotermia in Geratric Patients

This study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Cental National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 60 years old
  • Physical status ASA 1-3
  • Undergo elective surgery under general anesthesia with or without regional anesthesia

Exclusion Criteria:

  • Thermoregulation disturbance
  • Abnormal thyroid function
  • Fever caused by infectious disease in 7 days prior to surgery
  • Pre-induction hypothermia with temperature below 36 degree
  • On routine antipiretic
  • Unstable hemodynamic preoperative and intraoperative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: survival thermal blanket
Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia
Device: survival thermal blanket
patients were given a thermal blanket
Device: draping fabric
Patients were given a draping fabric
Active Comparator: draping fabric
Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia
Device: survival thermal blanket
patients were given a thermal blanket
Device: draping fabric
Patients were given a draping fabric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with hypothermia in survival thermal blanket group
Time Frame: Before induction
Measure by nasopharyngeal thermometer
Before induction
Number of participants with hypothermia in survival thermal blanket group
Time Frame: every 15 minute during anesthesia
Measure by nasopharyngeal thermometer
every 15 minute during anesthesia
Number of participants with hypothermia in survival thermal blanket group
Time Frame: end of surgery
Measure by nasopharyngeal thermometer
end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with hypothermia in draping fabric group
Time Frame: Before induction
Measure by nasopharyngeal thermometer
Before induction
Number of participants with hypothermia in draping fabric group
Time Frame: every 15 minute during anesthesia
Measure by nasopharyngeal thermometer
every 15 minute during anesthesia
Number of participants with hypothermia in draping fabric group
Time Frame: end of surgery
Measure by nasopharyngeal thermometer
end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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