Clinical Trials Logo

Clinical Trial Summary

There have been no fully validated tools for rapid screen of surgical patients at risk of intraoperative hypothermia. The aim of this study is to validate the performance of a previously established prediction model in estimating risk of intraoperative hypothermia using a prospective cohort before further implementation of the model. We hypothesize that the prediction model has helpful discrimination and adequate calibration [1] for clinical use.


Clinical Trial Description

This is a multicenter, prospective, observational cohort study to validate the property of a previously established mobile application (APP) [2] for estimating risk of intraoperative hypothermia. Patients scheduled for elective surgery under general anesthesia will be enrolled consecutively at 30 hospitals, which are randomly selected across China, between June, 2021 and December 2022. The total planned sample size is 3000 cases. Eligible participants will be identified, informed to sign the consent, and flagged at preoperative interview the day prior to the operation. Anesthetics and perioperative temperature management will be chosen at the discretion of the anesthesiologists without intervention. Intraoperative hypothermia risk score of each participant will be calculated by a mobile application of the predictor model [2] before surgery. A wireless axillary thermometer [3] will be used to continuously measure and record perioperative core temperature as the reference standard. All participants will be followed up until 30 days after the operation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05333120
Study type Observational [Patient Registry]
Source Peking Union Medical College Hospital
Contact Yuguang Huang, M.D.
Phone 00-86-010-13601121351
Email garybeijing@163.com
Status Recruiting
Phase
Start date May 25, 2021
Completion date December 2023

See also
  Status Clinical Trial Phase
Completed NCT01502163 - Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia N/A
Completed NCT05131568 - Thermal Insulation System in Inadvertent Hypothermia N/A
Completed NCT01858727 - The Effect of Preoperative Warming on Postoperative Hypothermia N/A
Terminated NCT01626690 - Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients Phase 4
Completed NCT03273894 - Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.
Active, not recruiting NCT02736630 - Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in Turkey N/A
Completed NCT06428604 - The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients
Completed NCT01795482 - Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery N/A