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

• Conditions: Perioperative Hypothermia

• Registration Number: NCT05333120
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study Start: 2021-05-25
• Study First Submitted: 2022-03-28
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-10
• Last Update Submitted: 2022-04-10
• Study First Posted: 2022-04-18
• Last Update Posted: 2022-04-18
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• aged 18 years or older
• undergoing elective operation with general anesthesia or combined with other anesthesia
• operation is expected to last more than 40 minutes

Exclusion Criteria

• central hyperthermia (e.g., cerebrovascular disease, traumatic brain injury, cerebral operation, epilepsy or acute hydrocephalus)
• impaired thermoregulation (e.g., neuroleptic malignant syndrome, malignant hyperthermia, or known hyperthyroidism/hypothyroidism with current thyroid dysfunction
• infectious fever
• core temperature ≥38.5 ℃ attributable to other causes within 3 days before surgery
• operation with induced hypothermia (e.g. cardiopulmonary bypass)
• unsuited for infrared tympanic thermometry or axillary temperature monitoring
• unwilling to give signed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
occurrence of perioperative hypothermia	during the perioperative period, an average of 2.5 hours	core temperature (measured by wireless axillary thermometer) \<36.0 ℃ at any time from admission to the preoperative holding area till discharge from post anesthesia care unit (PACU)

Secondary Outcome Measures

Name	Time	Method
amount of blood loss and blood transfusion	during the operation	amount of blood loss and blood transfusion during the operation
occurrence of shivering and thermal discomfort	during the perioperative period, an average of 2.5 hour	shivering and thermal discomfort occurring from admission to the preoperative holding area till discharge from post anesthesia care unit (PACU)
occurrence of surgical site infection (SSI)	during 30 days after the operation	definition of SSI is according to the CDC criterion in 2021 \[7\]
occurrence of death	during 30 days after the operation	death occurring in 30 days after the operation
duration of hospitalization	during hospitalization, an average of 10 days	time from hospital admission to hospital discharge
occurrence of myocardial injury non-cardiac surgery (MINS)	during 3 days after the operation	(1) a non-high-sensitivity troponin T ≥30ng/L, or (2) a high-sensitivity troponin T (hsTnT) ≥65ng/L, or (3) a hsTnT of 20 to \<65 ng/L with an absolute change of at least 5 ng/L, or (4) an elevation as any value above the 99th percentile upper reference limit for troponin I \[4-6\]

Trial Locations

Locations (1)

Department of Anesthesiology, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China