A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery

February 8, 2024 updated by: RenJi Hospital

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

Status

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Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

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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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Whether hypothermia occurs
Time Frame: 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.
Generally 1 ~ 3 hours, up to 3 hours can be observed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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