Laryngeal EdemaNCT07523828
Laryngeal Edema Assessment by Cuff Leak Test and Ultrasound in ICU Patients and Its Relationship With Weaning Success
An observational study of Laryngeal Edema, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Edema
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2026to 30 Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Ataşehir, 34752
About this study
Official title: 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
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.
Read the detailed description
Endotracheal intubation is one of the life-saving procedures used to support the respiratory system of critically ill patients on mechanical ventilation. In intubated patients, mechanical ventilation support is frequently applied in conditions such as acute respiratory failure or acute exacerbation of chronic respiratory failure where adequate oxygenation and/or ventilation cannot be achieved, loss of consciousness or airway reflexes, upper airway obstruction, and advanced life support in cardiac arrest; with the aim of improving gas exchange, reducing the work of breathing, or maintaining airway patency (1).
Airway complications may occur as a result of mechanical effects such as friction between the endotracheal tube and anatomical structures and prolonged compression. Prolonged intubation may cause partial airway obstruction, which can lead to laryngeal edema and post-extubation stridor (2). In patients receiving mechanical ventilation for 4 days or longer, mucosal ulcerations and laryngeal edema can be observed in almost all cases (3). Factors associated with post-extubation edema include advanced age, female gender, endotracheal tube size, presence of a cuffed endotracheal tube, prolonged duration of intubation, underlying airway disease, traumatic intubation, tracheal aspiration, tube mobility, and patient resistance to the tube (4). This may lead to sore throat, cough, dysphonia, dysphagia, and even respiratory failure requiring reintubation due to airway narrowing. Consequently, laryngeal edema in intensive care units (ICUs) is associated with longer durations of mechanical ventilation, increased hospital stay, higher morbidity and mortality, and significant economic costs (5).
"Weaning" is defined as the gradual reduction and discontinuation of mechanical ventilation support (6). The weaning process begins with the resolution of the cause of respiratory failure and results in the patient eventually breathing spontaneously. Weaning trials may fail due to increased work of breathing, laryngeal edema caused by prolonged intubation, electrolyte imbalances, malnutrition, hypothyroidism, major organ failure, and critical illness neuropathy (6).
Laryngeal edema causing post-extubation respiratory distress is usually the result of edema in the subglottic region and vocal cords (7). Examination of the vocal cords is typically performed using direct or indirect laryngoscopy. However, the presence of the endotracheal tube before extubation prevents direct visualization of the upper airway, making it difficult to detect laryngotracheal injury and edema.
The endotracheal tube cuff leak test is one of the most commonly used non-invasive and easily applicable bedside methods to assess airway anatomy and patency before extubation (6,8).
In recent years, ultrasound evaluation of the airway has emerged as an alternative to the cuff leak test for detecting laryngeal edema (6). Assessment of the larynx with airway ultrasound before extubation provides a fast, safe, real-time, bedside, and non-invasive method that helps predict the potential for post-extubation laryngeal edema. Using airway ultrasound, the air column passing between the vocal cords can be visualized, and its width is defined as the "laryngeal air column width" (9). Dynamic changes in the laryngeal air column during cuff deflation and inflation can be easily evaluated. Changes in air column dimensions reflect alterations in air leakage and airflow around the endotracheal tube (8). The "laryngeal air column width difference," defined as the difference between measurements taken with the cuff deflated and inflated, is important in detecting laryngeal edema (6).
In this prospective observational study, we aimed to investigate the relationship between weaning success and the endotracheal tube cuff leak test and ultrasound-measured laryngeal air column width difference in patients who were intubated for 24 hours or more in the ICU and planned for weaning. Our secondary objectives were to evaluate the presence of post-extubation stridor, sore throat, dysphonia, and dysphagia.
- Conditions
- Laryngeal Edema
- Keywords
- laryngeal edema, airway ultrasound, cuff leak test, weaning success
- Medical subject headings
- Laryngeal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours prior to extubation and during the weaning process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start8 Apr 2026 (estimated)
- Primary completion27 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laryngeal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Şimşek Ersöz, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- arzu yildirim ar, prof.dr., Study director, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523828
- Sponsor's protocol ID
- FSMTRH-AAR-BSE-01
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40999537Tsai 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.
PubMed 36744149Burton 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.
PubMed 37846938
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07523828
- Acronym / sponsor ID
- FSMTRH-AAR-BSE-01
- Conditions
- Laryngeal Edema
- Keywords
- laryngeal edema, airway ultrasound, cuff leak test, weaning success
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 8 Apr 2026 (estimated)
- Primary completion
- 27 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Endotracheal intubation is one of the life-saving procedures used to support the respiratory system of critically ill patients on mechanical ventilation. In intubated patients, mechanical ventilation support is frequently applied in conditions such as acute respiratory failure or acute exacerbation of chronic respiratory failure where adequate oxygenation and/or ventilation cannot be achieved, loss of consciousness or airway reflexes, upper airway obstruction, and advanced life support in cardiac arrest; with the aim of improving gas exchange, reducing the work of breathing, or maintaining airway patency (1).
Airway complications may occur as a result of mechanical effects such as friction between the endotracheal tube and anatomical structures and prolonged compression. Prolonged intubation may cause partial airway obstruction, which can lead to laryngeal edema and post-extubation stridor (2). In patients receiving mechanical ventilation for 4 days or longer, mucosal ulcerations and laryngeal edema can be observed in almost all cases (3). Factors associated with post-extubation edema include advanced age, female gender, endotracheal tube size, presence of a cuffed endotracheal tube, prolonged duration of intubation, underlying airway disease, traumatic intubation, tracheal aspiration, tube mobility, and patient resistance to the tube (4). This may lead to sore throat, cough, dysphonia, dysphagia, and even respiratory failure requiring reintubation due to airway narrowing. Consequently, laryngeal edema in intensive care units (ICUs) is associated with longer durations of mechanical ventilation, increased hospital stay, higher morbidity and mortality, and significant economic costs (5).
"Weaning" is defined as the gradual reduction and discontinuation of mechanical ventilation support (6). The weaning process begins with the resolution of the cause of respiratory failure and results in the patient eventually breathing spontaneously. Weaning trials may fail due to increased work of breathing, laryngeal edema caused by prolonged intubation, electrolyte imbalances, malnutrition, hypothyroidism, major organ failure, and critical illness neuropathy (6).
Laryngeal edema causing post-extubation respiratory distress is usually the result of edema in the subglottic region and vocal cords (7). Examination of the vocal cords is typically performed using direct or indirect laryngoscopy. However, the presence of the endotracheal tube before extubation prevents direct visualization of the upper airway, making it difficult to detect laryngotracheal injury and edema.
The endotracheal tube cuff leak test is one of the most commonly used non-invasive and easily applicable bedside methods to assess airway anatomy and patency before extubation (6,8).
In recent years, ultrasound evaluation of the airway has emerged as an alternative to the cuff leak test for detecting laryngeal edema (6). Assessment of the larynx with airway ultrasound before extubation provides a fast, safe, real-time, bedside, and non-invasive method that helps predict the potential for post-extubation laryngeal edema. Using airway ultrasound, the air column passing between the vocal cords can be visualized, and its width is defined as the "laryngeal air column width" (9). Dynamic changes in the laryngeal air column during cuff deflation and inflation can be easily evaluated. Changes in air column dimensions reflect alterations in air leakage and airflow around the endotracheal tube (8). The "laryngeal air column width difference," defined as the difference between measurements taken with the cuff deflated and inflated, is important in detecting laryngeal edema (6).
In this prospective observational study, we aimed to investigate the relationship between weaning success and the endotracheal tube cuff leak test and ultrasound-measured laryngeal air column width difference in patients who were intubated for 24 hours or more in the ICU and planned for weaning. Our secondary objectives were to evaluate the presence of post-extubation stridor, sore throat, dysphonia, and dysphagia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Can pre-weaning laryngeal edema be used to predict weaning success?
Time frame: Within 24 hours prior to extubation and during the weaning process
To evaluate whether laryngeal edema measured prior to weaning can predict weaning success in mechanically ventilated ICU patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 40999537Machefert 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.
- Background: PubMed 36744149Tsai 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.
- Results publication: PubMed 37846938Burton 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
arzu yildirim ar, prof.dr. study director
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Edema, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact busra simsek ersoz (+905315589464, busrasimsekersoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can pre-weaning laryngeal edema be used to predict weaning success? (time frame: Within 24 hours prior to extubation and during the weaning process). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07523828, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.