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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Mechanical Ventilator Weaning

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ahmed Atef Mohamed, MBBCh; Phone Number: +201006973892; Email: ahmed_ateff_post@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag Governorate
    • Sohag, Sohag Governorate, Egypt, 82524
      • Recruiting
      • Sohag University Hospital
      • Contact: Ahmed Atef Mohamed Sayed, MBBCh; Phone Number: +2001006973892; Email: atef53370@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUROC of conventional RSBI for prediction of successful weaning.	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.	Within 72 hours after extubation
Difference between AUROC values of D-RSBI and conventional RSBI	Comparison between AUROC values of D-RSBI and conventional RSBI for prediction of successful weaning.	Within 72 hours after extubation

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Diaphragm Ultrasound; Mechanical Ventilation Weaning; RSBI; D-RSBI
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Soh-Med-26-4-1MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No