Non-Invasive Ventilation in Pulmonary Edema

Last updated: March 28, 2007
Sponsor: Ospedale S. Giovanni Bosco
Overall Status: Completed

Phase

4

Condition

Blood Clots

Cardiovascular Disease

Lung Disease

Treatment

N/A

Clinical Study ID

NCT00453947
gbosco2
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • acute ischemic heart disease (myocardial infarction, chest pain, ST elevation)

  • hemodynamic instability (i.e. systolic blood pressure < 90 with dopamine or dobutamineinfusion ≥ 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 Groupperformance status ≥ 2

  • chronic respiratory failure necessitating long-term oxygen therapy

  • diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation ofchronic obstructive pulmonary disease, pneumothorax in the previous 3 months

  • denial or refusal of intubation

  • claustrophobia

  • inclusion in other research protocols

Study Design

Total Participants: 60
Study Start date:
July 01, 2002
Estimated Completion Date:
May 31, 2005

Study 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.

Connect with a study center

  • Ospedale San Giovanni Bosco Medicina d'Urgenza

    Torino, 10154
    Italy

    Site Not Available

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