Non-Invasive Ventilation in Pulmonary Edema

This study has been completed.
Sponsor:
Information provided by:
Ospedale S. Giovanni Bosco
ClinicalTrials.gov Identifier:
NCT00453947
First received: March 28, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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 Intervention Phase
Pulmonary Edema
Myocardial Infarction
Device: CPAP and Non Invasive Ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ospedale S. Giovanni Bosco:

Primary Outcome Measures:
  • The rate of Acute Myocardial Infarction

Secondary Outcome Measures:
  • Rate of endotracheal intubation
  • Mortality
  • Time of recovery (i.e. duration of ventilatory assistance)
  • High Dependency Unit and hospital length of stay

Estimated Enrollment: 60
Study Start Date: July 2002
Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453947

Locations
Italy
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
  More Information

No publications provided by Ospedale S. Giovanni Bosco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00453947     History of Changes
Other Study ID Numbers: gbosco2
Study First Received: March 28, 2007
Last Updated: March 28, 2007
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Infarction
Edema
Myocardial Infarction
Pulmonary Edema
Ischemia
Pathologic Processes
Necrosis
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014