Acute Respiratory FailureVeNIS BPCONCT01626937
Multicenter National Randomized Controlled Open Label Study Assessing Interest of Non Invasive Ventilation in out-of Hospital Setting During Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients. VeNIS BPCO
A study testing Non invasive ventilation and conventional medical treatment in people with Acute Respiratory Failure and Exacerbation of COPD, run by Centre Hospitalier d'Agen.
Trial summary
Goal of the study: To show that prehospital NPPV use for COPD decompensation, as compared to only standard medical treatment, might enable a decrease in intubation rate. Primary end point: the rate of endotracheal intubation in the first three hours after randomization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Exacerbation of COPD, Non Invasive Positive Pressure Ventilation
- What is being tested?
- Non invasive ventilation and conventional medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2014
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients ≥ 18 years,
- Glasgow Coma Scale (GCS) ≥ 10,
- Written consent,
- Beneficiary social security regiment,
- Known or suspected COPD,
- Acute respiratory failure with FR > 25cycles/min,
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- Setting concerned of the additional respiratory muscles and/or, paradoxical abdominal breathing,
- SpO2 < 90% with oxygen or decreasing rapidly under 90% with stop oxygen,
- PaCO2 > 45mmHg and pH < 7,35.
Who cannot join
- Cardiac or respiratory arrest,
- Upper gastro intestinal tract haemorrhage,
- Shock,
- Serious ventricular arrhythmia,
- Severe sepsis,
- Multiple organ failure,
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- Serious cranial-facial trauma,
- Upper airways obstruction,
- Undrained pneumothorax,
- Uncooperative-agitated patients refusing the technique,
- Respiratory distress with bradypnoea < 12/min, pauses gasps repeated bradycardia,
- Intractable vomiting,
- Acute traumatic tetraplegia,
- Persistant hemodynamic instability with PAS<90mmHg,
- Ensuitable environment,
- Acute coronary syndrome,
- Serious acute asthma,
- Acute pulmonary edema,
- Acute respiratory insufficiency with lung before healthy,
- Gas of blood non available.
Trial locations and contacts
No sites are listed yet.
About this study
Goal of the study: To show that prehospital NPPV use for COPD decompensation, as compared to only standard medical treatment, might enable a decrease in intubation rate.
Primary end point: the rate of endotracheal intubation in the first three hours after randomization.
Read more
Secondary en points: rate of endotracheal intubation after third hour, rate of prehospital and ICU mortality, ICU days, effects on clinical parameters (respiratory rate, SpO2, heart rate, arterial blood pressure, consciousness) and arterial blood gases (pH, PaCO2, PaO2), 30 days mortality, delays between first medical contact and in-hospital admission, relation between initial pH level and endotracheal intubation.
Inclusion criteria: Adult patients (>18 years), with GCS≥10, known or suspected COPD and presenting acute respiratory decompensation with respiratory acidosis.
Exclusion criteria: Cardiac or respiratory arrest, upper gastro intestinal tract haemorrhage, shock, serious ventricular arrhythmia, severe sepsis, multiple organ failure, serious cranial-facial trauma, upper airways obstruction, undrained pneumothorax, uncooperative-agitated patients refusing the technique, respiratory distress with bradypnoea < 12/min, pauses gasps repeated bradycardia, intractable vomiting, acute traumatic tetraplegia, persistant hemodynamic instability with PAS<90mmHg, ensuitable environment.
Randomization: Assignment to NPPV group or standard therapy group will be performed at the time of arrival of the SAMU team to the patient, by calling a physician located at the calldispatch center who will connect to the web site of the clinical research unit from Bordeaux university hospital.
Period of study: 25 months (24 months for patients inclusion and 1 month for follow-up).
Number of patients: 199 patients in each group i.e 398 patients (significance level of 5%, power of 80%; 50% expected decrease of intubation rate, i.e. from 20 to 10%).
Main investigator: Dr Pierre-Arnaud Fort, MD, Pôle Urgences-SAMU47-Réanimation, Centre Hospitalier Saint-Esprit - Agen.
Participating centers : 20 SAMU-SMUR corresponding to 19 departments in France.
- Conditions
- Acute Respiratory Failure, Exacerbation of COPD, Non Invasive Positive Pressure Ventilation, Out of Hospital Setting
- Being tested
- Non invasive ventilation, conventional medical treatment
- Keywords
- Acute respiratory failure, Chronic obstructive pulmonary disease, Non invasive ventilation, Out of hospital
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationOther
After nebulisation of bronchodilatators and administration of corticosteroid therapy, non invasive positive pressure ventilation will be started out of hospital and continuously in COPD patient with acute respiratory distress and respiratory acidosis, using a facial mask, with initial level of inspiratory pressure at 8 mmHg then according to VTe and/or respiratory rate; expiratory pressure at 4 mmHg then according to persistance of inspiratory work, level of FiO2 for an objective of SpO2 between 88 and 92%. In case of failure, NIV will be stopped and endotracheal intubation realized if indicate.
conventional medical treatmentOther
Conventional medical treatment includes nebulization of bronchodilatators every 15-20 minutes until hospital and corticosteroid therapy. If indicate during out of hospital setting, endotracheale intubation will be realized. After admission in hospital, non invasive ventilation could be started.
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation with conventional treatment | Experimental | Not described Receives: Other: Non invasive ventilation |
| conventional medical treatment | Active comparator | Not described Receives: Other: conventional medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of endotracheal intubation in the first three hours after randomization
Measured: third hour after randomization
Secondary outcomes (1)
rate of endotracheal intubation after third hour
Measured: after third hour during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier d'Agen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre-Arnaud FORT, Centre Hospitalier d'Agen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626937
- Sponsor's protocol ID
- 2011-A01382-39
- Acronym
- VeNIS BPCO
- Status last verified
- Jan 2012
- First submitted
- 21 Jun 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter National Randomized Controlled Open Label Study Assessing Interest of Non Invasive Ventilation in out-of Hospital Setting During Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients. VeNIS BPCO
- ClinicalTrials.gov ID
- NCT01626937
- Acronym / sponsor ID
- VeNIS BPCO / 2011-A01382-39
- Conditions
- Acute Respiratory Failure, Exacerbation of COPD, Non Invasive Positive Pressure Ventilation, Out of Hospital Setting
- Keywords
- Acute respiratory failure, Chronic obstructive pulmonary disease, Non invasive ventilation, Out of hospital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Centre Hospitalier d'AgenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Jun 2012 (estimated)
- 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.
Goal of the study: To show that prehospital NPPV use for COPD decompensation, as compared to only standard medical treatment, might enable a decrease in intubation rate.
Primary end point: the rate of endotracheal intubation in the first three hours after randomization.
Secondary en points: rate of endotracheal intubation after third hour, rate of prehospital and ICU mortality, ICU days, effects on clinical parameters (respiratory rate, SpO2, heart rate, arterial blood pressure, consciousness) and arterial blood gases (pH, PaCO2, PaO2), 30 days mortality, delays between first medical contact and in-hospital admission, relation between initial pH level and endotracheal intubation.
Inclusion criteria: Adult patients (>18 years), with GCS≥10, known or suspected COPD and presenting acute respiratory decompensation with respiratory acidosis.
Exclusion criteria: Cardiac or respiratory arrest, upper gastro intestinal tract haemorrhage, shock, serious ventricular arrhythmia, severe sepsis, multiple organ failure, serious cranial-facial trauma, upper airways obstruction, undrained pneumothorax, uncooperative-agitated patients refusing the technique, respiratory distress with bradypnoea < 12/min, pauses gasps repeated bradycardia, intractable vomiting, acute traumatic tetraplegia, persistant hemodynamic instability with PAS<90mmHg, ensuitable environment.
Randomization: Assignment to NPPV group or standard therapy group will be performed at the time of arrival of the SAMU team to the patient, by calling a physician located at the calldispatch center who will connect to the web site of the clinical research unit from Bordeaux university hospital.
Period of study: 25 months (24 months for patients inclusion and 1 month for follow-up).
Number of patients: 199 patients in each group i.e 398 patients (significance level of 5%, power of 80%; 50% expected decrease of intubation rate, i.e. from 20 to 10%).
Main investigator: Dr Pierre-Arnaud Fort, MD, Pôle Urgences-SAMU47-Réanimation, Centre Hospitalier Saint-Esprit - Agen.
Participating centers : 20 SAMU-SMUR corresponding to 19 departments in France.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation with conventional treatment | Experimental | Other: Non invasive ventilation |
| conventional medical treatment | Active comparator | Other: conventional medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients ≥ 18 years,
- Glasgow Coma Scale (GCS) ≥ 10,
- Written consent,
- Beneficiary social security regiment,
- Known or suspected COPD,
Key exclusion criteria (20 listed)
- Cardiac or respiratory arrest,
- Upper gastro intestinal tract haemorrhage,
- Shock,
- Serious ventricular arrhythmia,
- Severe sepsis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive ventilationAfter nebulisation of bronchodilatators and administration of corticosteroid therapy, non invasive positive pressure ventilation will be started out of hospital and continuously in COPD patient with acute respiratory distress and respiratory acidosis, using a facial mask, with initial level of inspiratory pressure at 8 mmHg then according to VTe and/or respiratory rate; expiratory pressure at 4 mmHg then according to persistance of inspiratory work, level of FiO2 for an objective of SpO2 between 88 and 92%. In case of failure, NIV will be stopped and endotracheal intubation realized if indicate. | Other | Non invasive ventilation with conventional treatment |
| conventional medical treatmentConventional medical treatment includes nebulization of bronchodilatators every 15-20 minutes until hospital and corticosteroid therapy. If indicate during out of hospital setting, endotracheale intubation will be realized. After admission in hospital, non invasive ventilation could be started. | Other | conventional medical treatment |
Primary outcome
rate of endotracheal intubation in the first three hours after randomization
Time frame: third hour after randomization
1 secondary outcome
rate of endotracheal intubation after third hour
Time frame: after third hour during hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation and conventional medical treatment in people with Acute Respiratory Failure and Exacerbation of COPD, run by Centre Hospitalier d'Agen.
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 9 inclusion and 20 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 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 pierre-arnaud fort (+33-0553697093, pierrearnaudf@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of endotracheal intubation in the first three hours after randomization (time frame: third hour after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2012.