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Not yet recruitingNCT05958550Updated Feb 9, 2024

A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery

An observational study in Hypothermia; Anesthesia, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
480
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hypothermia; Anesthesia

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03

In context

Hypothermia

449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's planned enrollment of 480 is above the median of 95 across 106 observational studies indexed under Hypothermia.

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Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
480 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hypothermia group

    Behavioral: The tympanic membrane temperature of patients was measured.

  • Non-hypothermia group

    Behavioral: The tympanic membrane temperature of patients was measured.

Interventions

  • BehavioralThe 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Generally 1 ~ 3 hours, up to 3 hours can be observed.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05958550
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Jul 24, 2023
Start date
Mar 12, 2024 (estimated)
Primary completion
Jun 12, 2025 (estimated)
Completion
Dec 12, 2025 (estimated)
Last update
Feb 9, 2024

Study contacts

sumin cui
Contact
515994172@qq.com
17621658300

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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