Clinical trial NCT05333120: Multi-center Validation of a Hypothermia Prediction Mobile Application (APP)
Official title: A Clinical Multicenter, Prospective, Observational Cohort Study to Validate a Prediction Mobile APP for Perioperative Hypothermia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Hypothermia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be selected from 30 hospitals which are randomly selected across China.

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.

Eligibility criteria: 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

Primary outcomes:
measure: occurrence of perioperative hypothermia
timeFrame: during the perioperative period, an average of 2.5 hours
Secondary outcomes:
measure: amount of blood loss and blood transfusion
timeFrame: during the operation
measure: occurrence of shivering and thermal discomfort
timeFrame: during the perioperative period, an average of 2.5 hour
measure: duration of hospitalization
timeFrame: during hospitalization, an average of 10 days
measure: occurrence of myocardial injury non-cardiac surgery (MINS)
timeFrame: during 3 days after the operation
measure: occurrence of surgical site infection (SSI)
timeFrame: during 30 days after the operation
measure: occurrence of death
timeFrame: during 30 days after the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Department of Anesthesiology, Peking Union Medical College Hospital
name: Yuguang Huang, M.D.
role: STUDY_CHAIR
References:
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citation: Yi J, Zhan L, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Yao M, Huang Y. Establishment and Validation of a Prediction Equation to Estimate Risk of Intraoperative Hypothermia in Patients Receiving General Anesthesia. Sci Rep. 2017 Oct 24;7(1):13927. doi: 10.1038/s41598-017-12997-x.
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