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

Recruiting

• Conditions: Laryngeal Edema

• Registration Number: NCT05611437
• Lead Sponsor: Groupe Hospitalier du Havre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-10
• Study Start: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema	Within the 24 hours following extubation	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders	Within the 24 hours following extubation	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.

Trial Locations

Locations (1)

Groupe Hospitalier du Havre; 🇫🇷 Montivilliers, France