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

Primary Purpose

Hypothermia; Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
survival thermal blanket
draping fabric
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia; Anesthesia focused on measuring perioperative hypothermia, geriatric, survival thermal blanket, draping fabric

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo Cental National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

survival thermal blanket

draping fabric

Arm Description

Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia

Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia

Outcomes

Primary Outcome Measures

Number of participants with hypothermia in survival thermal blanket group
Measure by nasopharyngeal thermometer
Number of participants with hypothermia in survival thermal blanket group
Measure by nasopharyngeal thermometer
Number of participants with hypothermia in survival thermal blanket group
Measure by nasopharyngeal thermometer

Secondary Outcome Measures

Number of participants with hypothermia in draping fabric group
Measure by nasopharyngeal thermometer
Number of participants with hypothermia in draping fabric group
Measure by nasopharyngeal thermometer
Number of participants with hypothermia in draping fabric group
Measure by nasopharyngeal thermometer

Full Information

First Posted
July 13, 2021
Last Updated
July 30, 2021
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04996407
Brief Title
Survival Thermal Blanket Versus Draping Fabric to Prevent Hypothermia in Geriatric Surgical Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia
Keywords
perioperative hypothermia, geriatric, survival thermal blanket, draping fabric

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
survival thermal blanket
Arm Type
Active Comparator
Arm Description
Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia
Arm Title
draping fabric
Arm Type
Active Comparator
Arm Description
Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia
Intervention Type
Device
Intervention Name(s)
survival thermal blanket
Intervention Description
patients were given a thermal blanket
Intervention Type
Device
Intervention Name(s)
draping fabric
Intervention Description
Patients were given a draping fabric
Primary Outcome Measure Information:
Title
Number of participants with hypothermia in survival thermal blanket group
Description
Measure by nasopharyngeal thermometer
Time Frame
Before induction
Title
Number of participants with hypothermia in survival thermal blanket group
Description
Measure by nasopharyngeal thermometer
Time Frame
every 15 minute during anesthesia
Title
Number of participants with hypothermia in survival thermal blanket group
Description
Measure by nasopharyngeal thermometer
Time Frame
end of surgery
Secondary Outcome Measure Information:
Title
Number of participants with hypothermia in draping fabric group
Description
Measure by nasopharyngeal thermometer
Time Frame
Before induction
Title
Number of participants with hypothermia in draping fabric group
Description
Measure by nasopharyngeal thermometer
Time Frame
every 15 minute during anesthesia
Title
Number of participants with hypothermia in draping fabric group
Description
Measure by nasopharyngeal thermometer
Time Frame
end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cipto Mangunkusumo Cental National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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