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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by Centre Hospitalier d'Agen
Sponsor:
Information provided by (Responsible Party):
Pierre-Arnaud FORT, Centre Hospitalier d'Agen
ClinicalTrials.gov Identifier:
NCT01626937
First received: June 21, 2012
Last updated: June 22, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Acute Respiratory Failure
Exacerbation of COPD
Non Invasive Positive Pressure Ventilation
Out of Hospital Setting
Other: Non invasive ventilation
Other: conventional medical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier d'Agen:

Primary Outcome Measures:
  • rate of endotracheal intubation in the first three hours after randomization [ Time Frame: third hour after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of endotracheal intubation after third hour [ Time Frame: after third hour during hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 398
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non invasive ventilation with conventional treatment Other: Non invasive ventilation
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.
Active Comparator: conventional medical treatment Other: conventional medical treatment
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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,
  • 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.

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,
  • Acute coronary syndrome,
  • Serious acute asthma,
  • Acute pulmonary edema,
  • Acute respiratory insufficiency with lung before healthy,
  • Gas of blood non available.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626937

Contacts
Contact: pierre-arnaud fort +33-0553697093 pierrearnaudf@yahoo.fr

Sponsors and Collaborators
Centre Hospitalier d'Agen
  More Information

No publications provided

Responsible Party: Pierre-Arnaud FORT, doctor, Centre Hospitalier d'Agen
ClinicalTrials.gov Identifier: NCT01626937     History of Changes
Other Study ID Numbers: 2011-A01382-39
Study First Received: June 21, 2012
Last Updated: June 22, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier d'Agen:
Acute respiratory failure
Chronic obstructive pulmonary disease
Non invasive ventilation
Out of hospital

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014