Ventilated Patient in Intensive CareNCT07467265
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
An observational study of Ventilated Patient in Intensive Care and Failure of Extubation, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Ventilated Patient in Intensive Care, Failure of Extubation
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mechnically ventilated patient eligable for extubation
Who may be able to join
- • 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.
Who cannot join
- Age <22 years.
- Refusal of informed consent.
- Altered mental status (e.g., traumatic brain injury).
- Hemodynamic instability or deep sedation (RASS ≤ -2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Keywords
- RSBI.VAP.success of extubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation success (no reintubation/adjuvant support within 48h).
no reintubation or adjuvant oxygen therapy
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilated Patient in Intensive CareStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah hamdy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467265
- Sponsor's protocol ID
- FAMSU R39/2026
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Shallow Index as Successfully Predictor of Outcome of Extubating
- ClinicalTrials.gov ID
- NCT07467265
- Acronym / sponsor ID
- FAMSU R39/2026
- Keywords
- RSBI.VAP.success of extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mechnically ventilated patient eligable for extubation
Key inclusion criteria (7 listed)
- • Adults > 22 years.
Key exclusion criteria (4 listed)
- Age <22 years.
- Refusal of informed consent.
- Altered mental status (e.g., traumatic brain injury).
- Hemodynamic instability or deep sedation (RASS ≤ -2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extubation success (no reintubation/adjuvant support within 48h).
Time frame: 48 hour
no reintubation or adjuvant oxygen therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Ventilated Patient in Intensive Care
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
Not yet recruitingPhase 3
Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilated Patient in Intensive Care and Failure of Extubation, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation success (no reintubation/adjuvant support within 48h). (time frame: 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.