Laryngeal Edema Assessment by Cuff Leak Test and Ultrasound in ICU Patients and Its Relationship With Weaning Success

NCT07523828 | Not Yet Recruiting

• 1 other identifier: FSMTRH-AAR-BSE-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates laryngeal edema in ICU patients during weaning from mechanical ventilation. It compares the cuff leak test and ultrasound-based laryngeal air column measurements in predicting weaning success. Ultrasound offers a non-invasive and real-time alternative for airway assessment. The study also examines post-extubation complications such as stridor, sore throat, dysphonia, and dysphagia.

Conditions

Laryngeal Edema

Keywords

laryngeal edema; airway ultrasound; cuff leak test; weaning success

Outcome Measures

Primary Outcomes (1)

• Can pre-weaning laryngeal edema be used to predict weaning success?

  To evaluate whether laryngeal edema measured prior to weaning can predict weaning success in mechanically ventilated ICU patients.

  Within 24 hours prior to extubation and during the weaning process

Study Arms (1)

Patients intubated for ≥24 hours in the ICU and undergoing weaning, evaluated with cuff leak test an

Patients intubated for ≥24 hours in the ICU and undergoing weaning, evaluated with cuff leak test and airway ultrasound before extubation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of intensive care patients over the age of 18 who are followed up with mechanical ventilation support and intubation for at least 24 hours at the Anesthesiology and Reanimation Clinic of Fatih Sultan Mehmet Training and Research Hospital and who have given informed consent by their guardian or parent.

You may qualify if:

• Patients who have been intubated and receiving invasive mechanical ventilation for at least 24 hours in the Intensive Care Unit of Fatih Sultan Mehmet Training and Research Hospital and who are considered by the intensive care physician to be ready for weaning from mechanical ventilation:
• Patients over 18 years of age
• Patients who have given their voluntary consent

You may not qualify if:

• Patients under 18 years of age
• Patients with a history of oral cavity surgery such as direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea,
• Patients with a history of allergy, asthma, reflux, upper respiratory tract viral or fungal infections, and cancer surgery,
• Patients who received radiotherapy to the neck region, or who had more than one intubation attempt in the previous year,
• Tracheostomized patients, patients with upper respiratory tract obstruction, vocal cord paralysis, and patients with stridor clinical picture before intubation,
• Patients for whom voluntary consent cannot be obtained

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

Related Publications (3)

• Machefert, M., Prieur, G., Díaz López, C., Dubois, C., Schnell, G., Artaud-Macari, E., Lamia, B., Combet, Y., & Medrinal, C. (2025). Oropharyngeal ultrafast ultrasound measurements in mechanically ventilated critically ill patients do not identify post-extubation stridor. Critical Care, 29, 406.

  BACKGROUND

• Tsai, W.-W., Hung, K.-C., Huang, Y.-T., Yu, C.-H., Lin, C.-H., Chen, I.-W., & Sun, C.-K. (2023). Diagnostic efficacy of sonographic measurement of laryngeal air column width difference for predicting the risk of post-extubation stridor: A meta-analysis of observational studies. Frontiers in Medicine, 10, 1109681.

  BACKGROUND

• Burton, L., Loberger, J., Baker, M., Prabhakaran, P., & Bhargava, V. (2024). Pre-extubation ultrasound measurement of in situ cuffed endotracheal tube laryngeal air column width difference: Single-center pilot study of relationship with post-extubation stridor in subjects younger than 5 years old. Pediatric Critical Care Medicine, 25(3), 222-229.

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Laryngeal Edema

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• arzu yildirim ar, prof.dr.

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

busra simsek ersoz

CONTACT

+905315589464; busrasimsekersoz@gmail.com

arzu yildirim ar, prof.dr.

CONTACT

+905053822729; dr.arzuyildirim@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT DOCTOR

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)