Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation
REVEAL
1 other identifier
observational
150
1 country
1
Brief Summary
In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%. Post-extubation stridor is a clinical sign of upper airway obstruction and may require urgent reintubation, which is associated with increased patient length of stay, morbidity and mortality. Identifying patients at risk is critical, and the need for reliable tools to predict the occurence of laryngeal edema is still relevant.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Dec 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedFebruary 24, 2023
February 1, 2023
1.8 years
October 10, 2022
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema
A laryngeal edema is defined as a post-extubation stridor. Performance of ultrafast ultrasonography for laryngeal edema prediction in intensive care patients will be assessed with specificity, sensitivity, positive predictive value and negative predictive value.
Within the 24 hours following extubation
Secondary Outcomes (1)
Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders
Within the 24 hours following extubation
Interventions
Ultrasonography of the neck, patient in supine position, neck hyper-extended. Three different scanning planes containing several landmarks. Carried out in the 12h prior extubation.
Eligibility Criteria
All adult patients admitted in Le Havre Hospital intensive care unit.
You may qualify if:
- Adults,
- Intubated and ventilated for more than 24h,
- Filing mechanical ventilation weaning criteria.
You may not qualify if:
- Pregnant of breast-feeding woman,
- Under guardianship patient,
- History of laryngeal tumor, stroke, paralysis of recurrent nerve, swallowing disorders,
- History of surgical laryngeal intervention or radiotherapy,
- Unplanned extubation,
- Opposition to take part in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier du Havre
Montivilliers, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2022
First Posted
November 10, 2022
Study Start
December 1, 2022
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
February 24, 2023
Record last verified: 2023-02