Cardiogenic Pulmonary Edema Clinical Trial
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. Compare the efficacy and safety of the NIPSV with those of CPAP in patients presenting
to the emergency department with CPE.
2. Compare the two procedures in subgroups of patients with hypercapnia and high BNP
concentration.
Cardiogenic pulmonary edema is defined as an increase of hydrostatic pressure in the
pulmonary microcirculation resulting from postcapillaire hypertension.
The direct consequence is extravasation of fluid in the alveolar and interstitial tissue,
leading to acute hypoxemia and a decrease in lung compliance. The decrease in lung
compliance, increased airway resistance (interstitial and bronchial edema) and hypoxemia will
cause an increase in work of breathing. The imbalance between the ability of respiratory
muscles to generate effective gas exchange and exaggerated ventilatory load can lead to
respiratory muscle fatigue requiring use of mechanical ventilation through endotracheal
prosthesis. In addition, the increase in inspiratory muscles work during the CPE generates
very important pleural depression, which increases transmural pressure and left ventricular
afterload and thus increases pulmonary edema.
The CPAP is a non-invasive ventilation mode most currently used CPE. It is usually obtained
via a mask and an expiratory valve to maintain constant pressure in the circuit. No
inspiratory assistance is provided to the patient. The BOUSSIGNAC valve is currently used in
clinical practice as an adjunct to the pharmacological treatment of CPE.The effect of CPAP is
mainly linked to its ability to recruit zones that are collapsed during expiration. • NIPSV
combines a positive expiratory pressure to ventilatory assistance pressure during inspiration
delivered by a ventilator. It corresponds to a CPAP associated with inspiratory assistance,
and thus, it is likely to improve the ventilation parameters, and in particular to reduce
respiratory work more efficiently than CPAP alone.These beneficial physiological effects of
NIPSV were well demonstrated during the decompensation of COPD ; they wait to be confirmed
during CPE. Physiological studies have shown that the NIPSV is more effective in terms of
reducing the work of breathing in CPE. However, none of the 7 published randomized studies
has shown superiority of the NIPSV compared to CPAP in terms of reducing mortality and
intubation requirement
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04971213 -
HIgh Flow Versus NIV for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
|
N/A | |
| Completed |
NCT01680783 -
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
|
N/A | |
| Completed |
NCT04005092 -
Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema
|
N/A | |
| Recruiting |
NCT06107257 -
Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
|
||
| Completed |
NCT03041428 -
Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO)
|
N/A | |
| Completed |
NCT00390442 -
Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema
|
Phase 3 |