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Clinical Trials/NCT05611437
NCT05611437
Recruiting
Not Applicable

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

Groupe Hospitalier du Havre1 site in 1 country150 target enrollmentDecember 1, 2022
ConditionsLaryngeal Edema

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laryngeal Edema
Sponsor
Groupe Hospitalier du Havre
Enrollment
150
Locations
1
Primary Endpoint
Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
August 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema

Time Frame: 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 Outcomes

  • Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders(Within the 24 hours following extubation)

Study Sites (1)

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