NCT07467265

Brief 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. This study aims to determine the predictive value of RSBI measurements for extubation success in mechanically ventilated ICU patients

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Mar 2026Sep 2026

Study Start

First participant enrolled

March 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 9, 2026

Last Update Submit

March 11, 2026

Conditions

Ventilated Patient in Intensive CareFailure of Extubation

Keywords

RSBI.VAP.success of extubation

Outcome Measures

Primary Outcomes (1)

  • Extubation success (no reintubation/adjuvant support within 48h).

    no reintubation or adjuvant oxygen therapy

    48 hour

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

mechnically ventilated patient eligable for extubation

You may qualify if:

  • 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.

You may not qualify if:

  • Age \<22 years.
  • Refusal of informed consent.
  • Altered mental status (e.g., traumatic brain injury).
  • Hemodynamic instability or deep sedation (RASS ≤ -2).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Hospital

Cairo, Abbasia, 1181, Egypt

RECRUITING

Central Study Contacts

Sarah hamdy Elghareeb, MD

CONTACT

+201012434690sarahhamdy@med.asu.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia,icu and pain management

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)