Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation

Laryngeal Edema Clinical Trial

— REVEAL  

Official title:

Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611437
• Other study ID #: 2022-A01363-40
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2023
• Source: Groupe Hospitalier du Havre
• Contact: Clement Medrinal
• Phone: 0630039745
• Email: medrinal.clement.mk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults,

• Intubated and ventilated for more than 24h,

• Filing mechanical ventilation weaning criteria.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Laryngeal Edema

Intervention

Other:
• Ultrafast ultrasonography
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.

Locations

Country	Name	City	State
France	Groupe Hospitalier du Havre	Montivilliers

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders	Performance of ultrafast ultrasonography for swallowing disorsders prediction in intensive care patients will be assessed with specificity, sensitivity, positive predictive value and negative predictive value.	Within the 24 hours following extubation