CClinicalTrials.gg
Sign In
RecruitingNCT07590362Updated May 15, 2026

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

An observational study in Chronic Obstructive Pulmonary Disease (COPD) and Mechanical Ventilator Weaning, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Mechanical Ventilator Weaning

Keywords

  • D-RSBI
  • RSBI
  • COPD
  • Diaphragm Ultrasound
  • Mechanical Ventilation Weaning
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 100 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: Within 72 hours after extubation

Secondary outcomes

  1. 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.

    Time frame: Within 72 hours after extubation

  2. 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.

    Time frame: Within 72 hours after extubation

07

Study locations

1 of 1 sites recruiting
  • Sohag University Hospital
    Sohag, Sohag Governorate 82524, Egypt
    Recruiting
08

References and documents

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. PubMed 28864053 ↗
  • 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. PubMed 2023603 ↗
  • 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. PubMed 27677861 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07590362
Lead sponsor
Sohag University
Responsible party
Ahmed Atef Mohamed (Resident of Anesthesia, ICU and Pain Management faculty of medicine Sohag University, Sohag University) — Principal investigator
First posted
May 15, 2026
Start date
Apr 15, 2026
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
May 15, 2026

Study contacts

Ahmed Atef Mohamed, MBBCh
Contact
ahmed_ateff_post@med.sohag.edu.eg
+201006973892

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pulmonary Disease, Chronic Obstructive→

Other studies from this sponsor

Sohag University

Start the discussion