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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia

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