Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study

NCT00785174 | Completed Phase 3

• 1 other identifier: NIV-CPAP-CPE
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Non-invasive ventilation (NIV) has become now a widely used treatment modality in ICU and emergency services to deal with respiratory failure.1 NIV has the potential to improve ventilatory assistance while avoiding endotracheal intubation and its complications. Since the first publications of Meduri2 and Brochard3 the number of studies on the NIV has been growing and developing and this technique becomes one of the major progress in the field of respiratory assistance. Decompensation of chronic obstructive pulmonary disease (COPD) is certainly the least questionable indication of the NIV. However, indication of the NIV is inexorably spreading to other types of acute respiratory insufficiency, including acute cardiogenic pulmonary edema (CPE).4 Continuous positive airway pressure (CPAP) is the most currently used non-invasive ventilation usually performed without the use of a ventilator. NIV using pressure support (NIPSV) combined pressure support (inspiratory aid) and positive expiratory pressure as in CPAP. Based on physiological ground, NIPSV would be more performant than CPAP to improve ventilatory parameters and reduce the work breathing in APE. However, this issue is not settled yet. Number of meta-analysis over the last 2 years were devoted to the comparison of CPAP and NISPV,5 so that the scientific evidence is still far from established. In addition, it is not sur that patients enrolled in these studies are representative of all patients with APE. The fact that they were included solely on the basis of clinical criteria, the risk of overlap with other diagnoses is not negligible. Thus the use of markers of heart failure as the BNP (brain natriuretic peptide) would be very useful. On the other hand, the possible deleterious effect of NIPSV on myocardial perfusion is a problem that has not been definitively resolved. Objectives of the study:

1. 1.Compare the efficacy and safety of the NIPSV with those of CPAP in patients presenting to the emergency department with CPE.
2. 2.Compare the two procedures in subgroups of patients with hypercapnia and high BNP concentration.

Conditions

Cardiogenic Pulmonary Edema

Keywords

noninvasive ventilation, continuous posi

Outcome Measures

Primary Outcomes (2)

• It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.

  6 hours and 30 days after protocol start

• Primary outcome It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.

  6 hours and 30 days after protocol start

Secondary Outcomes (2)

• The change in the rate of troponin

  6 hours after protocol start

• The length of hospital stay

  30 days after protocol start

Study Arms (2)

continuous positive airway pressure

ACTIVE COMPARATOR

respiratory assistance

Device: continuous positive airway pressure

NIPSV

ACTIVE COMPARATOR

respiratory assistance using face mak and ventilator to provide inspiratory pressure support and positive end expiratory pressure

Device: noninvasive pressure support ventilation

Interventions

continuous positive airway pressure DEVICE

respiratory assistance using face mask and positive expiratory pressure apllied by a Boussignac valve

Also known as: Boussignac CPAP

continuous positive airway pressure

noninvasive pressure support ventilation DEVICE

noninvasive pressure support ventilation can provide inspiratory pressure support and expiratory positive pressure

Also known as: NIPSV

NIPSV

Eligibility Criteria

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

You may qualify if:

• All patients aged \>18 years and having acute respiratory failure caused by CPE.
• The origin of cardiogenic pulmonary edema is defined according to the history and clinical presentation, the chest X-ray and / or data of echocardiography when they are available with a serum BNP\> 100pg/ml.
• The acute respiratory failure is defined by the existence of clinical signs and / or arterial gas parameters:
• sweats and / or agitation and / or signs of struggle and /or drowsiness
• dyspnea with respiratory rate \> 35/min,
• a blood oxygen saturation ≤ 90% by air.

You may not qualify if:

• Instability of the hemodynamic state (severe rhythm disturbances, hypotension with systolic arterial pressure \<50 mmHg, need for inotropic drugs).
• The need for immediate endotracheal intubation.
• Contraindications to the use of a facial or nasal mask (or facial skin lesion).
• History of recent gastrointestinal surgery or pseudo obstruction.
• Refusal of participation or non-cooperation of the patient.

Sponsors & Collaborators

• University of Monastir: lead

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: January 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 5, 2008

Record last verified: 2008-11