NCT06570486

Brief Summary

This experiment is an observational study of cohort. By establishing a cohort of patients with head and neck tumors transferred to ICU after surgery, investigators compared the prediction effect of AI and the traditional prediction model on whether patients can be transferred to ICU within 24 hours of head and neck tumors. First retrospective analysis of patients after head and neck tumor surgery, medical records were collected, the test results are divided into training group and validation group according to 7:3, divided into 2 groups according to the patient ICU stay time is greater than 24 hours, the prediction model after the ICU duration of head and neck tumor surgery after more than 24 hours. At the same time, clean the data, train the AI with the data, and compare the effectiveness of both sides with the ROC. After the establishment of prediction model and AI training, the patients included in the cohort were evaluated by prediction model and AI immediately after being transferred to the ICU, predicting the possibility of transferring out of the ICU within 24 hours.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

July 23, 2024

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • roll-out icu

    The time of patient transfer from ICU to the general ward was set as transfer out

    From the date of ICU admission until the date of ICU discharge or death, whichever occurs first, assessed up to 30 days

Study Arms (3)

training group

For training models

test group

Used to validate the model

Prospective cohort

For the prospective validation of the model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Head and neck tumor postoperative patient transferred to icu

You may qualify if:

  • Patients after head and neck tumors;
  • older than 18 years.

You may not qualify if:

  • Patients transferred to ICU twice after head and neck tumors;
  • Patients with unplanned transfer to the ICU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 52100, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 26, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2024

Study Completion

April 1, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

If others need it, they can apply to us for the data, and we will provide it.

Locations