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

Not Applicable

Completed

• Conditions: Hypothermia; Anesthesia
• Interventions: Device: survival thermal blanket; Device: draping fabric

• Registration Number: NCT04996407
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2021-03-05
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-30
• Last Update Submitted: 2021-07-30
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
survival thermal blanket	survival thermal blanket	Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia
draping fabric	draping fabric	Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia
survival thermal blanket	draping fabric	Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia
draping fabric	survival thermal blanket	Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia

Primary Outcome Measures

Name	Time	Method
Number of participants with hypothermia in survival thermal blanket group	end of surgery	Measure by nasopharyngeal thermometer

Secondary Outcome Measures

Name	Time	Method
Number of participants with hypothermia in draping fabric group	end of surgery	Measure by nasopharyngeal thermometer

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia