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

NCT07081399 | Recruiting Early Phase 1

• 1 other identifier: 1a2b3c4d5e6f7g8h9i10j11k12l13m
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia; Dysphagia Rehabilitation

Keywords

post-extubation dysphagia; post-extubation laryngospasm

Outcome Measures

Primary Outcomes (3)

• prevention of laryngeal edema

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

  72 hours after extubation

• laryngospasm

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

  72 hours after extubation

• dysphagia

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

  72 hours after extubation

Study Arms (2)

non-clinical pathway group

NO INTERVENTION

non-clinical pathway group who received the routine hospital care.

clinical pathway group

EXPERIMENTAL

the clinical pathway group who recieved the CP interventions such as: ETTcuff pressure measurement, ETT suctioning, measures to prevent laryngeal edema, swallowing rehabilitation, maneuvers to prevent laryngospasm

Interventions

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• patients admitted with high risk for laryngeal edema,
• difficult intubation,
• ETT/anterior-posterior diameter ˃45%,
• self-extubation, and
• planned for tracheostomy.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Faculty of Nursing, Damanhour University

Damanhūr, Egypt, Egypt

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• sahar youness effect of adult intubated CP on post-extubation complications

  STUDY CHAIR

Central Study Contacts

heba attia effect of adult intubated CP on post-extubation complications

CONTACT

045 01274855242; heba.attia@nur.dmu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: post-extubation complications outcomes (laryngospasm, laryngeal edema and dysphagia)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer critical care and emergency nursing

Model Details: non- clinical pathway group and clinical pathway group

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: July 23, 2025
• Study Start: August 8, 2024
• Primary Completion: March 8, 2025
• Study Completion: August 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)