The Relationship Between Assessment of Laryngeal Edema in Intensive Care Patients Using Cuff Leak Test and Ultrasound-Guided Laryngeal Air Column Width Difference and Weaning Success
Sponsor study identifier
observational
100
1 country
1
Study Start
April 8, 2026
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Primary Completion
August 27, 2026
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Study Completion
August 30, 2026
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 5, 2026
Actual (reported)April 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 13, 2026
Actual (reported)August 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Patients intubated for ≥24 hours in the ICU and undergoing weaning, evaluated with cuff leak test and airway ultrasound before extubation.
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.
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Ataşehir, 34752, Turkey (Türkiye)
Machefert M, Prieur G, Diaz Lopez C, Dubois C, Schnell G, Artaud-Macari E, Lamia B, Combret Y, Medrinal C. Oropharyngeal ultrafast ultrasound measurements in mechanically ventilated critically ill patients do not identify post-extubation stridor. Crit Care. 2025 Sep 25;29(1):406. doi: 10.1186/s13054-025-05659-2.
Tsai WW, Hung KC, Huang YT, Yu CH, Lin CH, Chen IW, Sun CK. 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. Front Med (Lausanne). 2023 Jan 19;10:1109681. doi: 10.3389/fmed.2023.1109681. eCollection 2023.
arzu yildirim ar, prof.dr.
Fatih Sultan Mehmet Training and Research Hospital
First Submitted
April 5, 2026
First Posted
April 13, 2026
Study Start
April 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 27, 2026
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Burton L, Loberger J, Baker M, Prabhakaran P, Bhargava V. 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. Pediatr Crit Care Med. 2024 Mar 1;25(3):222-230. doi: 10.1097/PCC.0000000000003377. Epub 2023 Oct 16.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 13, 2026
Record last verified: 2026-03
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