A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery

Not yet recruiting

• Conditions: Hypothermia; Anesthesia
• Interventions: Behavioral: The tympanic membrane temperature of patients was measured.

• Registration Number: NCT05958550
• Lead Sponsor: RenJi Hospital

Brief Summary

The incidence of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors is high. Hypothermia increases the risk of postoperative complications and medical costs. Early warning can effectively reduce the incidence of postoperative hypothermia in patients. Multivariate prediction models help identify high-risk patients and reversible factors. At present, there are few reports on the risk factors and prediction models of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. Therefore, this study aims to clarify the risk factors of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. Four machine learning algorithms, traditional Logistic regression analysis, decision tree, random forest and naive Bayes, were used to establish risk prediction models. According to the TRIPOD statement, C-index, Hosmer-Lemeshow ( H-L ) test and decision curve analysis ( DCA ) were used to evaluate the prediction and fitting effects of the models in all aspects, and the optimal model was selected and verified. Provide reference for subsequent research.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09
• Study Start: 2024-03-12
• Primary Completion: 2025-06-12
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• The types of surgery included laparoscopic radical gastrectomy for gastric cancer, duodenal cancer, colon cancer, rectal cancer and small bowel cancer. Age ≥ 18 years ; the anesthesia method was general anesthesia ; elective surgery.

Exclusion Criteria

• Patients with abnormal body temperature such as fever and hypothermia before operation ; patients who need low temperature to protect organs during operation ; patients who were converted to laparotomy during the operation ; a clear diagnosis of sweat gland dysfunction ; patients with external auditory canal active disease ; reject participants.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-hypothermia group	The tympanic membrane temperature of patients was measured.	-
Hypothermia group	The tympanic membrane temperature of patients was measured.	-

Primary Outcome Measures

Name	Time	Method
Whether hypothermia occurs	Generally 1 ~ 3 hours, up to 3 hours can be observed.	If the patient 's body temperature is lower than 36 °C during this period, it will be determined that the patient has a postoperative hypothermia, and the rewarming measures will be implemented according to the doctor 's advice. If the patient 's body temperature data collected during this period were all greater than or equal to 36 ° C and less than or equal to 37.2 ° C, it was determined that the patient 's body temperature was normal during the postoperative recovery period and no postoperative hypothermia occurred.