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Prevalence of an Early Success of Non-invasive Ventilation in the Emergency Departement.

NCT06213623 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-01-23

No results posted yet for this study

Summary

Non-invasive ventilation is a mechanical ventilation who provides ventilatory support through a facemask, and without the need for tracheal intubation. In the emergency department, non-invasive ventilation is commonly used for the management of acute respiratory failure related with acute exacerbation of chronic obstructive pulmonary disease or with cardiogenic pulmonary oedema. Non-invasive ventilation is associated with an improvement in the outcomes, such as a decreasing in the intubation rate and in the mortality rate. Non-invasive ventilation failure is defined by a requirement to tracheal intubation in a patient managed by non-invasive ventilation. In the intensive care unit, non-invasive ventilation failure is reported from 15 to 50% of patients according to the ARF aetiologies. Due to delayed intubation, non-invasive ventilation failure is associated with poor outcomes and an increasing in the mortality rate. Due to the emergency department's patients (older and/or not to be intubate patients) the actual definition of non-invasive ventilation failure could not be applied as non-invasive ventilation may have been stopped not because it was unsuccessful but because it was unsuccessful in a patient with a do not intubate decision. Consequently, the prevalence of the absence of non-invasive ventilation success in the emergency department is unclear, and its predictive factor are unknown.

The aim is to measure the prevalence of the absence of non-invasive ventilation success in the emergency department. The secondary objective is to measure the association between an absence of non-invasive ventilation success and outcomes and to identify risk factor of an absence of non-invasive ventilation success in the emergency department.

It's a prospective observationnal multicenter study in department of Initiative Recherche Urgences Study Groups from January 2024, 15th to January 2024, 20th. The Initiative Recherche Urgences is a research network set up on the initiative of the Société Française de Médecine d'Urgence, with the aim of promoting and coordinating multicentre research projects in the field of emergency medicine, during short inclusion periods.

The primary outcome is the proportion of patients who do not have an early success of non-invasive ventilation. The investigators measure the absence of success instead of failure because failure is defined by intubation and most of patients managed with non-invasive ventilation in an emergency department will not be intubated because of their age. The absence of success is defined by at least one of the following criteria measured at 1-hour: death, cardiorespiratory arrest, tracheal intubation, respiratory rate over 30 breaths/min, neurological impairment defined by a Glasgow coma scale \< 14, signs of increased work of breathing, haemodynamic failure (defined by mean arterial pressure \< 65 mmHg despite volumetric expansion and/or catecholamines), early stop of non-invasive ventilation due to intolerance. The investigators choose to measure at one hour because non-invasive ventilation is provided from one to two hours in the emergency department.

Conditions

  • Non Invasive Ventilation
  • Acute Respiratory Failure

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Jeremie LESTIENNE, MD PHD · CHU Poitiers

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-01-27
Completion
2024-01-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06213623 on ClinicalTrials.gov