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Respiratory Distress Syndrome (RDS)NCT07065838

Using Artificial Intelligence Models for Predicting The Need for Intubation and Successful Weaning From Mechanical Ventilation in ICU Patients

An observational study of Respiratory Distress Syndrome (RDS), run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Respiratory Distress Syndrome (RDS)
How many people
600 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 1 Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients admired to Intensive care units of Assiut University Hospitals

Who may be able to join

  • 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.

Who cannot join

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

About this study

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).

Read the detailed description

Intubation is a medical procedure that involves inserting a breathing tube into a patient's airway to prevent suffocation and provide assistance with breathing. This intervention is commonly performed in the Intensive Care Unit (ICU) when patients are unable to clear secretions or breathe independently, Intubation is particularly beneficial for patients with conditions such as emphysema, collapsed lungs, pneumonia and pulmonary edema, allowing them to breathe effectively, However, accurate prediction of the timing of intubation remains an unsolved challenge due to the noisy, heterogeneous, and unbalanced nature of ICU data. So, determining the optimal timing for intubation is a stressful task for medical personnel, as delays can worsen patient outcomes and increase morbidity and mortality.

Also, estimating an appropriate weaning time from mechanical ventilation is an essential clinical decision in critical care. Premature attempts to extubate patients increase the risk of ventilator-associated pneumonia, prolonged intensive care unit (ICU) stay, and mortality. Meanwhile, an unnecessarily prolonged duration of mechanical ventilation causes an enormous economic health burden and is associated with deteriorated clinical outcomes .

Previously proposed weaning indices have shown conflicting results, as over one-quarter of patients require reintubation despite meeting the criteria for such indices, such as the rapid shallow breathing index (RSBI) . Therefore, an accurate prediction tool for deciding when patients are ready for extubation is critical for managing patients with respiratory failure.

Artificial intelligence models have emerged as promising solutions for tackling these challenges. These technologies have the potential to learn from data and predict the optimal intubation timing. Unlike medical professionals, machine learning models are not affected by personal emotions.

Regarding 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. Also, regarding weaning decision support; Machine learning algorithms analyzing integrated parameters 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. Once the model has done enough learning, the trained model can be easily deployed with low costs at various ICUs.

This study aims to 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' decision. Then assess whether AI-assisted decisions improve patient outcomes (e.g., reduced intubation delays, shorter ventilation duration).

Study tools include collecting patients data and AI model development;

  1. Data collection: All participates will be subjected to
  2. Baseline data: Demographics ( age, sex, weight, length) , comorbidities (DM, HTNs ,chronic kidney disease… ), APACHE II score, reason for mechanical ventilation.
  3. Daily data:
  4. Resolution of the underlying condition: The primary reason for mechanical ventilation should be resolved or significantly improved.
  5. Hemodynamic stability: blood pressure and heart rate without significant vasopressor support. c- oxygenation: - PaO₂ ≥ 60 mmHg on FiO₂ ≤ 0.4. - PEEP ≤ 5-8 cm H₂O. - Oxygen saturation (SpO₂) ≥ 90%. d- ventilation: - PaCO₂ within normal limits or at the patient's baseline. - pH ≥ 7.25.
  • Normal electrolyte levels: K, Mg, phosphate
  • fluid balance.
  • Normal metabolic status: No significant acidosis or alkalosis.
  • hemoglobin levels: > 7 g/dL
  1. Respiratory Mechanics
  • (RR): < 35 breaths/min.
  • Tidal volume : > 5 mL/kg ideal body weight.
  • Minute ventilation (VE): < 10-15 L/min.
  • Rapid shallow breathing index : < 105 breaths/min/L (measured during a spontaneous breathing trial).
  • Endotracheal cuff leak test. f. Neurological Status
  • mental status: Patient should be awake, alert, and able to protect their airway.
  • Cough and gag reflex
  • Minimal sedation g. Others
  • Infection control: No active infection or fever that could impair weaning.
  • Pain management 3- Outcome data: Duration of ventilation, ICU length of stay, complications, reintubation rates. b.AI model development :
  1. model choice
  2. model training and validation; Split Data 70% training, 15% validation, 15% testing
  3. performance metrics , AUC-ROC, sensitivity , specificity, F1-score, calibration (Brier score).
Medical subject headings
Respiratory Distress Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07065838
Sponsor's protocol ID
AI and mechanical ventilation
Status last verified
Jun 2025
First submitted
14 Jun 2025
Last updated
15 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Distress Syndrome (RDS), run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perfect time to intubate and to Wean (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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