Rapid Shallow Breathing Index to predict extubation success in mechanically ventilated ICU patients
Rapid Shallow Index as Successfully Predictor of Outcome of Extubating
Ain Shams University · NCT07467265
This project will test whether the Rapid Shallow Breathing Index (RSBI) helps doctors predict which adult ICU patients can be successfully taken off mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo, Abbasia) |
| Trial ID | NCT07467265 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll mechanically ventilated adults at Ain Shams Hospital who meet predefined extubation readiness criteria and record RSBI values during spontaneous breathing trials. Patients with RSBI ≤ 105 breaths/min/L combined with a passing SBT will be followed for extubation outcomes including need for reintubation. The analysis will compare RSBI alone and the combined SBT+RSBI approach against actual extubation success to determine predictive value. The cohort includes postoperative, elective/emergency reintubation, and tracheostomized patients while excluding those with altered mental status, deep sedation, or hemodynamic instability.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients older than 22 years on mechanical ventilation who meet oxygenation, respiratory, hemodynamic, and neurologic readiness criteria for a spontaneous breathing trial.
Not a fit: Patients with altered mental status, deep sedation, hemodynamic instability, or who do not meet readiness criteria for an SBT are unlikely to benefit from the RSBI-based decision approach studied here.
Why it matters
Potential benefit: If successful, combining RSBI with SBT criteria could improve timing of extubation and reduce failed extubations and complications from prolonged ventilation.
How similar studies have performed: RSBI and SBT combinations have been widely used in prior work and shown modest predictive value, but optimal thresholds and combined criteria remain debated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • Adults \> 22 years.
* Mechanically ventilated patients meeting extubation readiness:
* FiO₂ ≤ 0.4, PEEP ≤ 8 cmH₂O, PaO₂/FiO₂ ≥ 200 mmHg.
* Respiratory rate ≤ 35 breaths/min, pH \> 7.30.
* Hemodynamic stability (HR ≤ 120 bpm, SBP 90-160 mmHg).
* Glasgow Coma Scale \>10, adequate cough reflex.
* Includes postoperative, elective/emergency reintubation, and tracheostomized patients.
Exclusion Criteria:
* Age \<22 years.
* Refusal of informed consent.
* Altered mental status (e.g., traumatic brain injury).
* Hemodynamic instability or deep sedation (RASS ≤ -2).
Where this trial is running
Cairo, Abbasia
- Ain Shams Hospital — Cairo, Abbasia, Egypt (RECRUITING)
Study contacts
- Study coordinator: Sarah hamdy Elghareeb, MD
- Email: sarahhamdy@med.asu.edu.eg
- Phone: +201012434690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventilated Patient in Intensive Care, Failure of Extubation, RSBI.VAP.success of extubation