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

NCT ID: NCT04996407

Last Updated: 2021-08-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2021-04-30

Brief Summary

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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

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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.

Conditions

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Hypothermia; Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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survival thermal blanket

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

Group Type ACTIVE_COMPARATOR

survival thermal blanket

Intervention Type DEVICE

patients were given a thermal blanket

draping fabric

Intervention Type DEVICE

Patients were given a draping fabric

draping fabric

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

Group Type ACTIVE_COMPARATOR

survival thermal blanket

Intervention Type DEVICE

patients were given a thermal blanket

draping fabric

Intervention Type DEVICE

Patients were given a draping fabric

Interventions

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survival thermal blanket

patients were given a thermal blanket

Intervention Type DEVICE

draping fabric

Patients were given a draping fabric

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Aida Rosita Tantri

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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IndonesiaUAnes108

Identifier Type: -

Identifier Source: org_study_id

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