Non-Invasive Ventilation in Pulmonary Edema

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453947
• Other study ID #: gbosco2
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2007
• Last updated: March 28, 2007
• Start date: July 2002
• Est. completion date: May 2005

Study information

• Verified date: March 2007
• Source: Ospedale S. Giovanni Bosco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Infarction
• Myocardial Infarction
• Pulmonary Edema

Intervention

Device:
• CPAP and Non Invasive Ventilation

Locations

Country	Name	City	State
Italy	Ospedale San Giovanni Bosco Medicina d'Urgenza	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale S. Giovanni Bosco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Acute Myocardial Infarction
Secondary	Rate of endotracheal intubation
Secondary	Mortality
Secondary	Time of recovery (i.e. duration of ventilatory assistance)
Secondary	High Dependency Unit and hospital length of stay