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.
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 Type
OBSERVATIONAL
Enrollment
3,000
Department of Anesthesiology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGoccurrence of perioperative hypothermia
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)
Time frame: during the perioperative period, an average of 2.5 hours
amount of blood loss and blood transfusion
amount of blood loss and blood transfusion during the operation
Time frame: during the operation
occurrence of shivering and thermal discomfort
shivering and thermal discomfort occurring from admission to the preoperative holding area till discharge from post anesthesia care unit (PACU)
Time frame: during the perioperative period, an average of 2.5 hour
duration of hospitalization
time from hospital admission to hospital discharge
Time frame: during hospitalization, an average of 10 days
occurrence of myocardial injury non-cardiac surgery (MINS)
(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 \[4-6\]
Time frame: during 3 days after the operation
occurrence of surgical site infection (SSI)
definition of SSI is according to the CDC criterion in 2021 \[7\]
Time frame: during 30 days after the operation
occurrence of death
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death occurring in 30 days after the operation
Time frame: during 30 days after the operation