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NCT04996407 Clinical Trial

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

Hypothermia; Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04996407
Other study ID # IndonesiaUAnes108
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2021
Est. completion date April 30, 2021

Study information
Verified date July 2021
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• survival thermal blanket
patients were given a thermal blanket
• draping fabric
Patients were given a draping fabric

Locations
Country Name City State
Indonesia Cipto Mangunkusumo Cental National Hospital Jakarta DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with hypothermia in survival thermal blanket group Measure by nasopharyngeal thermometer Before induction
Primary Number of participants with hypothermia in survival thermal blanket group Measure by nasopharyngeal thermometer every 15 minute during anesthesia
Primary Number of participants with hypothermia in survival thermal blanket group Measure by nasopharyngeal thermometer end of surgery
Secondary Number of participants with hypothermia in draping fabric group Measure by nasopharyngeal thermometer Before induction
Secondary Number of participants with hypothermia in draping fabric group Measure by nasopharyngeal thermometer every 15 minute during anesthesia
Secondary Number of participants with hypothermia in draping fabric group Measure by nasopharyngeal thermometer end of surgery
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