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Completed

NCT Number: NCT04996407

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

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.

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Key information

Conditions

Hypothermia; Anesthesia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

survival thermal blanket

Device

patients were given a thermal blanket

draping fabric

Device

Patients were given a draping fabric

Primary outcomes

  1. Number of participants with hypothermia in survival thermal blanket group

    Time frame: Before induction

    Measure by nasopharyngeal thermometer

  2. Number of participants with hypothermia in survival thermal blanket group

    Time frame: every 15 minute during anesthesia

    Measure by nasopharyngeal thermometer

  3. Number of participants with hypothermia in survival thermal blanket group

    Time frame: end of surgery

    Measure by nasopharyngeal thermometer

Secondary outcomes

  1. Number of participants with hypothermia in draping fabric group

    Time frame: Before induction

    Measure by nasopharyngeal thermometer

  2. Number of participants with hypothermia in draping fabric group

    Time frame: every 15 minute during anesthesia

    Measure by nasopharyngeal thermometer

  3. Number of participants with hypothermia in draping fabric group

    Time frame: end of surgery

    Measure by nasopharyngeal thermometer

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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