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

NCT01626937 | Unknown

• 1 other identifier: 2011-A01382-39
• Study Type: interventional
• Target: 398
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Acute respiratory failure; Chronic obstructive pulmonary disease; Non invasive ventilation; Out of hospital

Outcome Measures

Primary Outcomes (1)

• rate of endotracheal intubation in the first three hours after randomization

  third hour after randomization

Secondary Outcomes (1)

• rate of endotracheal intubation after third hour

  after third hour during hospitalization

Study Arms (2)

Non invasive ventilation with conventional treatment

EXPERIMENTAL

Other: Non invasive ventilation

conventional medical treatment

ACTIVE COMPARATOR

Other: conventional medical treatment

Interventions

Non invasive ventilation OTHER

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.

Non invasive ventilation with conventional treatment

conventional medical treatment OTHER

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.

conventional medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Centre Hospitalier d'Agen: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

pierre-arnaud fort

CONTACT

+33-0553697093; pierrearnaudf@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 25, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 25, 2012

Record last verified: 2012-01