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NCT Number: NCT07590362

D-RSBI Versus RSBI for Predicting Weaning Success in COPD Patients

This prospective observational cohort study aims to compare the predictive accuracy of diaphragmatic rapid shallow breathing index (D-RSBI) versus traditional rapid shallow breathing index (RSBI) for predicting weaning success from invasive mechanical ventilation in COPD patients. Diaphragmatic ultrasound measurements will be performed during spontaneous breathing trials, and patients will be followed for 72 hours after extubation to assess weaning outcomes.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Mechanical Ventilator Weaning Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University Hospital

Sohag, Sohag Governorate, 82524, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mechanically ventilated COPD patients fulfilling standard weaning readiness criteria.
  • Invasive mechanical ventilation for more than 24 hours before spontaneous breathing trial.
  • Hemodynamically stable without significant vasopressor support.
  • Adequate oxygenation with FiO2 ≤ 0.5 and PEEP ≤ 8 cmH2O .
  • Preserved mental status and ability to initiate spontaneous breathing.
  • Successful tolerance of spontaneous breathing trial conducted on CPAP mode with pressure support ≤ 8 cmH2O.

Exclusion criteria

  • Refusal of consent
  • Neuromuscular disease, phrenic nerve palsy, or diaphragmatic paralysis.
  • Large pneumothorax or pathology interfering with ultrasound assessment.
  • Terminal extubation.
  • Recent major thoracic surgery.
  • Poor sonographic window despite repeated attempts.

Treatment and study plan

Primary outcomes

  1. AUROC of D-RSBI for prediction of successful weaning

    Time frame: Within 72 hours after extubation

    Area under the receiver operating characteristic curve (AUROC) of diaphragmatic rapid shallow breathing index (D-RSBI) for predicting successful weaning within 72 hours after extubation in mechanically ventilated COPD patients.

Secondary outcomes

  1. AUROC of conventional RSBI for prediction of successful weaning.

    Time frame: Within 72 hours after extubation

    Area under the receiver operating characteristic curve (AUROC) of conventional rapid shallow breathing index (RSBI) for predicting successful weaning within 72 hours after extubation in mechanically ventilated COPD patients.

  2. Difference between AUROC values of D-RSBI and conventional RSBI

    Time frame: Within 72 hours after extubation

    Comparison between AUROC values of D-RSBI and conventional RSBI for prediction of successful weaning.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Diaphragmatic Rapid Shallow Breathing Index (D-RSBI) Versus Traditional Rapid Shallow Breathing Index (RSBI) for Prediction of Weaning Success From Mechanical Ventilation in COPD Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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