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

NCT07590362 | Recruiting

• 1 other identifier: Soh-Med-26-4-1MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilator Weaning; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

D-RSBI; RSBI; COPD; Diaphragm Ultrasound; Mechanical Ventilation Weaning

Outcome Measures

Primary Outcomes (1)

• AUROC of D-RSBI for prediction of successful weaning

  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.

  Within 72 hours after extubation

Secondary Outcomes (2)

• AUROC of conventional RSBI for prediction of successful weaning.

  Within 72 hours after extubation

• Difference between AUROC values of D-RSBI and conventional RSBI

  Within 72 hours after extubation

Study Arms (1)

Mechanically Ventilated COPD Patients

COPD patients receiving invasive mechanical ventilation who fulfill weaning readiness criteria and undergo spontaneous breathing trial with assessment of D-RSBI and conventional RSBI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated adult COPD patients admitted to the intensive care units of Sohag University Hospitals and fulfilling standard weaning readiness criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, 82524, Egypt

RECRUITING

Related Publications (3)

• Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.

  PMID: 28864053 BACKGROUND

• Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50. doi: 10.1056/NEJM199105233242101.

  PMID: 2023603 BACKGROUND

• Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.

  PMID: 27677861 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Atef Mohamed, MBBCh

CONTACT

+201006973892; ahmed_ateff_post@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, ICU and Pain Management faculty of medicine Sohag University

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 15, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)