Non-Invasive Ventilation in Pulmonary Edema

Ospedale S. Giovanni Bosco

Status and phase

Completed

Phase 4

Conditions

Myocardial Infarction

Pulmonary Edema

Treatments

Device: CPAP and Non Invasive Ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT00453947

gbosco2

Details and patient eligibility

About

This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure.

Full description

Objective: To determine whether the application of non-invasive intermittent positive pressure ventilation (n-IPPV) increases the incidence of acute myocardial infarction (AMI) in patients with acute respiratory failure (ARF) secondary to acute cardiogenic pulmonary edema (ACPE), as opposed to non-invasive continuous positive airway pressure (n-CPAP).

Background Both n-CPAP or n-IPPV are used to treat ACPE complicated by ARF. Two previous studies, however, report an increased rate of AMI associated with the use of n-IPPV.

Methods: Fifty-two patients with severe ARF consequent to ACPE were randomized to receive n-CPAP (n=27) or n-IPPV (n=25), both associated with standard medical therapy. Cardiac markers, electrocardiogram and clinical-physiological parameters were monitored at study entry, after 30 and 60 minutes, and every 6 hours for the first two days.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

rapid onset of the symptoms
severe dyspnoea at rest
respiratory rate > 30 breaths per minute
use of accessory respiratory muscles
oxygen saturation (SpO2) inferior to 90% with an inspiratory oxygen fraction of 60% via a Venturi mask
radiological findings of ACPE

Exclusion criteria

acute ischemic heart disease (myocardial infarction, chest pain, ST elevation)
hemodynamic instability (i.e. systolic blood pressure < 90 with dopamine or dobutamine infusion ≥ 5 mcgr/Kg/min) or life-threatening arrhythmias
need for immediate endotracheal intubation (respiratory arrest, bradypnea or gasping)
inability to protect the airways
impaired sensorium (i.e. unconsciousness or agitation)
inability to clear secretions
respiratory tract infection
recent oesophageal/gastric surgery
gastrointestinal bleeding
facial deformities
hematological malignancy or cancer with an Eastern Cooperative Oncology Group performance status ≥ 2
chronic respiratory failure necessitating long-term oxygen therapy
diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease, pneumothorax in the previous 3 months
denial or refusal of intubation
claustrophobia
inclusion in other research protocols