NCT07065838

Brief Summary

Using artificial intelligence (AI) approach to build a model to determine the optimal timing of intubation and optimal timing of weaning from MV for ICU patients, and compare outcomes with these which depend on clinicians dicision. And also assess whether AI-assisted decisions improve patient outcomes (e.g., reduced intubation delays, shorter ventilation duration).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Oct 2025

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Oct 2025Nov 2027

First Submitted

Initial submission to the registry

June 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

June 14, 2025

Last Update Submit

July 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perfect time to intubate and to Wean

    1. Intubation Prediction: AI models incorporating time-series analysis of respiratory rate variability, oxygen saturation trends, and evolving PaO2/FiO2 ratios can predict impending respiratory failure with greater accuracy than conventional clinical assessment. Early identification of high-risk patients may reduce emergency intubations and their associated complications. 2. Weaning Decision Support: Machine learning algorithms analyzing integrated parameters (RSBI, MIP/NIF, compliance trends) during spontaneous breathing trials demonstrate superior prediction of extubation success compared to traditional weaning indices. Recent studies show AI-guided protocols can reduce ventilator days by 1.8 days (95% CI 0.5-3.1) without increasing reintubation rates. These systems function as cognitive aids, processing multidimensional data at a scale beyond human capacity while preserving clinician judgment.

    2 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admired to Intensive care units of Assiut University Hospitals

You may qualify if:

  • Adult patients (≥18 years) in ICUs at risk of respiratory failure.
  • Adults (≥18 years) receiving mechanical ventilation for \>24 hours and deemed ready for weaning.

You may not qualify if:

  • \- Patients with a pre-existing "Do Not Intubate" (DNI) order.
  • \- Patients with irreversible neurological conditions affecting weaning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 14, 2025

First Posted

July 15, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

July 15, 2025

Record last verified: 2025-06