- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467265
The Rapid Shallow Breathing Index (RSBI) is a Widely Used Predictor for Weaning Patients From Mechanical Ventilation This Study Aims to Determine the Predictive Value of RSBI Measurements for Extubation Success in Mechanically Ventilated ICU Patients
March 11, 2026 updated by: sarah hamdy, Ain Shams University
Rapid Shallow Index as Successfully Predictor of Outcome of Extubating
Early extubation in ICU patients is crucial for reducing complications of prolonged ventilation, including morbidity and mortality.
The Rapid Shallow Breathing Index (RSBI) is a widely used predictor for weaning patients from mechanical ventilation.
This study aims to determine the predictive value of RSBI measurements for extubation success in mechanically ventilated ICU patients
Study Overview
Status
Recruiting
Detailed Description
The extubation decision is a combined clinical judgment based on a passing Spontaneous Breathing Trial (SBT) and a Rapid Shallow Breathing Index (RSBI) value ≤ 105 breaths/min/L.combination of criteria (SBT + RSBI threshold) This approach is recommended to improve predictive accuracy, as neither SBT nor RSBI alone is perfectly reliable.
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah hamdy Elghareeb, MD
- Phone Number: +201012434690
- Email: sarahhamdy@med.asu.edu.eg
Study Locations
-
-
Abbasia
-
Cairo, Abbasia, Egypt, 1181
- Recruiting
- Ain Shams Hospital
-
Contact:
- Sarah Elghareeb
- Phone Number: 01012434690
- Email: sarahhamdy@med.asu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
mechnically ventilated patient eligable for extubation
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Extubation success (no reintubation/adjuvant support within 48h).
Time Frame: 48 hour
|
no reintubation or adjuvant oxygen therapy
|
48 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 9, 2026
First Posted (Actual)
March 12, 2026
Study Record Updates
Last Update Posted (Actual)
March 13, 2026
Last Update Submitted That Met QC Criteria
March 11, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FAMSU R39/2026
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
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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