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Non-Invasive Ventilation in Pulmonary Edema

Sponsor
Ospedale S. Giovanni Bosco (Other)
Overall Status
Completed
CT.gov ID
NCT00453947
Collaborator
(none)
60
Enrollment
1
Location
34
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: CPAP and Non Invasive Ventilation
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non Invasive Positive Airway Pressure And Risk Of Myocardial Infarction In Acute Cardiogenic Pulmonary Edema: Continuous Positive Airway Pressure Vs Non Invasive Positive Pressure Ventilation
Study Start Date :
Jul 1, 2002
Actual Study Completion Date :
May 1, 2005

Outcome Measures

Primary Outcome Measures

  1. The rate of Acute Myocardial Infarction []

Secondary Outcome Measures

  1. Rate of endotracheal intubation []

  2. Mortality []

  3. Time of recovery (i.e. duration of ventilatory assistance) []

  4. High Dependency Unit and hospital length of stay []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale San Giovanni Bosco Medicina d'Urgenza Torino Italy 10154

Sponsors and Collaborators

  • Ospedale S. Giovanni Bosco

Investigators

  • Principal Investigator: Giovanni Ferrari, MD, Ospedale San Giovanni Bosco ASL4 Torino Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00453947
Other Study ID Numbers:
  • gbosco2
First Posted:
Mar 29, 2007
Last Update Posted:
Mar 29, 2007
Last Verified:
Mar 1, 2007
Additional relevant MeSH terms:
Pulmonary Edema
Myocardial Infarction
Infarction
Edema

Study Results

No Results Posted as of Mar 29, 2007