Clinical pathway to prevent post-extubation complications in intubated adults
the Effect of Adult Intubated Patient Clinical Pathway on Post-extubation Complications Prevention
This tests a clinical pathway for adults recently removed from a breathing tube to reduce swallowing problems and airway spasms after extubation.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Damanhour University Academic / other |
| Locations | 1 site (Damanhūr, Egypt) |
| Trial ID | NCT07081399 on ClinicalTrials.gov |
What this trial studies
This interventional, early-phase study implements a multi-component clinical pathway for adult patients after endotracheal tube removal. Interventions include monitoring endotracheal tube cuff pressure, targeted suctioning, cough augmentation, swallowing exercises, nebulized budesonide (1 mg), and intravenous methylprednisolone (40 mg). Eligible patients are adults (>18) who are orally intubated for the first time, mechanically ventilated for under two weeks, and have a Glasgow Coma Scale of 13–15, while exclusions include high risk for laryngeal edema, difficult intubation, large ETT diameter ratios, self-extubation, or planned tracheostomy. The primary goal is to reduce post-extubation laryngeal edema, laryngospasm, and dysphagia and to support faster recovery at a single center in Damanhūr, Egypt.
Who should consider this trial
Good fit: Adults over 18 who are being orally intubated for the first time, have been on mechanical ventilation for less than two weeks, and have a GCS of 13–15.
Not a fit: Patients with high risk for laryngeal edema, known difficult airways, an ETT-to-trachea diameter ratio above the specified cutoff, those who self-extubate, or those planned for tracheostomy are excluded and are unlikely to benefit.
Why it matters
Potential benefit: If successful, the pathway could lower rates of post-extubation dysphagia and airway complications, speeding recovery and reducing ICU-related problems.
How similar studies have performed: Previous small trials and steroid use have shown mixed but sometimes positive effects on reducing laryngeal edema and post-extubation airway problems, while bundled clinical pathways have limited high-quality evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years) * orally intubated patients for the first time attached with MV for less than two weeks * with Glasgow coma scale (GCS) from 13-15. Exclusion Criteria: * patients admitted with high risk for laryngeal edema, * difficult intubation, * ETT/anterior-posterior diameter ˃45%, * self-extubation, and * planned for tracheostomy.
Where this trial is running
Damanhūr, Egypt
- Faculty of Nursing, Damanhour University — Damanhūr, Egypt, Egypt (Recruiting)
Study contacts
- Study coordinator: heba attia effect of adult intubated CP on post-extubation complications
- Email: heba.attia@nur.dmu.edu.eg
- Phone: 045 01274855242
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.