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Trial Title:
A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery
NCT ID:
NCT05958550
Condition:
Hypothermia; Anesthesia
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Hypothermia
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
The tympanic membrane temperature of patients was measured.
Description:
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.
Arm group label:
Hypothermia group
Arm group label:
Non-hypothermia group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Start date:
March 12, 2024
Completion date:
December 12, 2025
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05958550
