A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05958550
Collaborator
(none)
480
28

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The tympanic membrane temperature of patients was measured.

Study Design

Study Type:
Observational
Anticipated Enrollment :
480 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Construction and Validation of a Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery Based on Machine Learning
Anticipated Study Start Date :
Aug 12, 2023
Anticipated Primary Completion Date :
Jun 12, 2025
Anticipated Study Completion Date :
Dec 12, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT05958550
Other Study ID Numbers:
  • LY2023-072-B
First Posted:
Jul 24, 2023
Last Update Posted:
Jul 24, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2023