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Non-Invasive Ventilation in Pulmonary Edema

Primary Purpose

Pulmonary Edema, Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
CPAP and Non Invasive Ventilation
Sponsored by
Ospedale S. Giovanni Bosco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ospedale San Giovanni Bosco Medicina d'Urgenza

Outcomes

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

Full Information

First Posted
March 28, 2007
Last Updated
March 28, 2007
Sponsor
Ospedale S. Giovanni Bosco
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1. Study Identification

Unique Protocol Identification Number
NCT00453947
Brief Title
Non-Invasive Ventilation in Pulmonary Edema
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 Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ospedale S. Giovanni Bosco

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CPAP and Non Invasive Ventilation
Primary Outcome Measure Information:
Title
The rate of Acute Myocardial Infarction
Secondary Outcome Measure Information:
Title
Rate of endotracheal intubation
Title
Mortality
Title
Time of recovery (i.e. duration of ventilatory assistance)
Title
High Dependency Unit and hospital length of stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Ferrari, MD
Organizational Affiliation
Ospedale San Giovanni Bosco ASL4 Torino Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Giovanni Bosco Medicina d'Urgenza
City
Torino
ZIP/Postal Code
10154
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17908705
Citation
Ferrari G, Olliveri F, De Filippi G, Milan A, Apra F, Boccuzzi A, Converso M, Navalesi P. Noninvasive positive airway pressure and risk of myocardial infarction in acute cardiogenic pulmonary edema: continuous positive airway pressure vs noninvasive positive pressure ventilation. Chest. 2007 Dec;132(6):1804-9. doi: 10.1378/chest.07-1058. Epub 2007 Oct 1.
Results Reference
derived

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Non-Invasive Ventilation in Pulmonary Edema

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