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Non Invasive VentilationVENTIRUNCT06213623

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

An observational study of Non Invasive Ventilation and Acute Respiratory Failure, run by Poitiers University Hospital at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
500 participants
Where
1 siteFrance
Study dates
15 Jan 2024to 27 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted in an intrahospital or pre-hospital emergency department and managed with non invasive ventilation

Who may be able to join

  • Age equal or over 18 years old
  • Patient admitted in an intrahospital or pre-hospital emergency department
  • Patient managed with non invasive ventilation
  • No objection to the use of data

Who cannot join

  • Minors, incapacitated adults or patients deprived of their liberty.
  • Patient with a care limitation, instruction not to be reanimated.
  • Contraindication to initiation of nonninvasive ventilation at the start of management (non-COPD coma< 10 non-COPD, hemodynamic failure, incoercible vomiting)
  • Patient who have low autonomy as defined by a WHO score ≥ 3 (bedridden for more than 50% of the day, not confined to it)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Poitiers University Hospital

    Poitiers, 86021

    Jérémie LESTIENNE, MD PHD, 0549444444 ext. +33, jeremie.lestienne@chu-poitiers.fr

    Nicolas MARJANOVIC, MD PHD, 0549441873 ext. +33, nicolas.marjanovic@chu-poitiers.fr

Other trials in France

About this study

Official title: Prevalence of an Early Success of Non-invasive Ventilation in the Emergency Departement. A Prospective Observational Study of the "Initiative Recherche Urgences" Network

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.

Read more

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who do not have an early success of non invasive ventilation

    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.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start15 Jan 2024 (estimated)
  3. Primary completion27 Jan 2024 (estimated)
  4. Study completion27 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06213623
Sponsor's protocol ID
VENTIRU
Acronym
VENTIRU
Status last verified
Jan 2024
First submitted
9 Jan 2024
Last updated
23 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Marjanovic N, Lestienne J, Balen F, Coisy F, Gerlier C, Guenezan J, Mimoz O; SFMU-IRU network. Prevalence, risk factors and consequences of early clinical deterioration under non-invasive ventilation in emergency department patients: a prospective, multicentre, observational study of the French IRU Network. Crit Care. 2025 Jun 3;29(1):224. doi: 10.1186/s13054-025-05430-7.

    PubMed 40462106

Questions about this trial

What is this clinical trial studying?

An observational study of Non Invasive Ventilation and Acute Respiratory Failure, run by Poitiers University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jeremie LESTIENNE, MD PHD (0549444444 ext. +33, jeremie.lestienne@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who do not have an early success of non invasive ventilation (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06213623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

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