Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05292937 - Incidence of Perioperative Hypothermia in Pediatric Patients
Completed NCT05516771 - Evaluation of a Licensed Double-sensor-heat-flux (DHF) Non-invasive Core Temperature Sensor in Small Children and Toddlers Undergoing Surgery
Not yet recruiting NCT05426278 - The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting N/A
Completed NCT06010069 - The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores
Completed NCT03157609 - Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children? N/A
Recruiting NCT05349734 - Comparison of Underbody and Overbody Forced Air Blanket in Pediatric Patients Undergoing Cardiovascular Interventions N/A
Completed NCT03111875 - Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery N/A
Completed NCT03527329 - Perioperative Hypothermia in Patients Submitted to Transurethral Resection
Not yet recruiting NCT05958550 - A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery
Completed NCT05215834 - The Comparison of Remimazolam With Propofol in Core Body Temperature Phase 4
Completed NCT04252820 - Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia N/A
Completed NCT04935632 - Perioperative Collection of Temperatures and Hypothermia
Completed NCT04709627 - enFlow IV Fluid and Blood Warming System
Not yet recruiting NCT05430997 - Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery N/A
Completed NCT04027842 - Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia N/A
Completed NCT05213377 - Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty N/A
Completed NCT04686214 - Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery N/A
Recruiting NCT04410068 - Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia N/A
Recruiting NCT03473470 - Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery N/A
Completed NCT04033900 - Effects of Active Prewarming in Perioperative Hypothermia in Adults N/A