NCT05333120

Multi-center Validation of a Hypothermia Prediction Mobile Application (APP)

A Clinical Multicenter, Prospective, Observational Cohort Study to Validate a Prediction Mobile APP for Perioperative Hypothermia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Perioperative Hypothermia

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-04-18
• Last updated: 2022-04-18

Locations

1 site across 1 country: China