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.
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
- Conditions the study is for
- Non Invasive Ventilation, Acute Respiratory Failure
- 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
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.
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.
- First posted19 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion27 Jan 2024 (estimated)
- Study completion27 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Invasive VentilationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremie LESTIENNE, MD PHD, Principal investigator, CHU Poitiers
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06213623
- Acronym / sponsor ID
- VENTIRU / VENTIRU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 27 Jan 2024 (estimated)
- Study completion
- 27 Jan 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in an intrahospital or pre-hospital emergency department and managed with non invasive ventilation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who do not have an early success of non invasive ventilation
Time frame: 1 hour
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 40462106Marjanovic 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.
Related trials for Non Invasive Ventilation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Validation of the Turkish Version of the S3-NIV Questionnaire
Respiratory Insufficiency, Chronic Respiratory Failure
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremie LESTIENNE, MD PHD principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
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.