A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery

Construction and Validation of a Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery Based on Machine Learning

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypothermia; Anesthesia
• Intervention / Treatment: Behavioral: The tympanic membrane temperature of patients was measured.

• Study Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

• Study Contact: Name: sumin cui; Phone Number: 17621658300; Email: 515994172@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

From June 2023 to January 2024, patients underwent laparoscopic gastrointestinal tumor surgery in the East Hospital of Renji Hospital, Shanghai Jiaotong University School of Medicine.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypothermia group	Behavioral: The tympanic membrane temperature of patients was measured.; After the patient entered the anesthesia recovery room ( PACU ) at the end of the operation, the ear canal was cleaned with cotton swabs by nurses trained in the use of ear temperature guns to avoid the impact of earwax. The patient was in a supine position, the patient 's head was fixed, the patient 's auricle was gently pulled back and up, the ear canal was straight, the ear temperature gun was put into the ear canal, the temperature of the patient 's left and right ears was measured uniformly, and the average value was taken as the final body temperature value. Thereafter, the same measurement was performed every 20 minutes until the patient left the resuscitation room.
Non-hypothermia group	Behavioral: The tympanic membrane temperature of patients was measured.; After the patient entered the anesthesia recovery room ( PACU ) at the end of the operation, the ear canal was cleaned with cotton swabs by nurses trained in the use of ear temperature guns to avoid the impact of earwax. The patient was in a supine position, the patient 's head was fixed, the patient 's auricle was gently pulled back and up, the ear canal was straight, the ear temperature gun was put into the ear canal, the temperature of the patient 's left and right ears was measured uniformly, and the average value was taken as the final body temperature value. Thereafter, the same measurement was performed every 20 minutes until the patient left the resuscitation room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whether hypothermia occurs	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.	Generally 1 ~ 3 hours, up to 3 hours can be observed.

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 12, 2024
• Primary Completion (Estimated): June 12, 2025
• Study Completion (Estimated): December 12, 2025

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Body Temperature Changes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Hypothermia
• Other Study ID Numbers: LY2023-072-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No