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NCT Number: NCT07081399

the Effect of Adult Intubated Patient Clinical Pathway on Post-extubation Complications Prevention

Post- extubation complications delay the complete recovery of critically ill patient. The clinical pathway is one strategies that help to manage and control these complications.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Dysphagia Rehabilitation Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Nursing, Damanhour University

Damanhūr, Egypt

Location status: Recruiting

About this study

The presence of endotracheal tube is associated with various fatal complications which are diagnosed mainly in post- extubation time. Those complications include laryngeal edema, laryngospasm, and post-extubation dysphagia which delay the complete recovery of critically ill patient. The clinical pathway is one of the excellent strategies that help the critical care staff to manage and control these complications

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ETT cuff pressure monitoring, ETT suctioning, cough augmentation technique, swallowing exercises,: Nebulized budesonide 1mg and IV methylprednisolone 40 mg we

Combination Product

cough augmentation, larson maneuver, swallowing rehabilitation

Primary outcomes

  1. prevention of laryngeal edema

    Time frame: 72 hours after extubation

    measured by respiratory distress observation score that it ranges from 0-16. the high score indicates sever respiratory distress

  2. laryngospasm

    Time frame: 72 hours after extubation

    measured by four point scale. it composed from 4 grades, grade 0 indicates no laryngospasm, grade 3 indicates severe degree of laryngospasm.

  3. dysphagia

    Time frame: 72 hours after extubation

    measured by Gugging Swallowing Screen scale that it ranges from 0 -20. the high score indicates severe dysphagia

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Acronym: CP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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