NCT00453947

CompletedPhase 4

Non-Invasive Ventilation in Pulmonary Edema

Ospedale S. Giovanni Bosco Source

Ospedale S. Giovanni Bosco

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

gbosco2

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

July 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

May 2005

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: May 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
May 2005
Actual (reported)
First Submitted
March 28, 2007
Actual (reported)
First Posted
March 29, 2007
Actual (reported)

Last Updated: March 29, 2007
Status Verified: March 2007
Last Update Submitted: March 28, 2007

Conditions

Myocardial Infarction Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

The rate of Acute Myocardial Infarction

Secondary Outcomes (4)

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

Interventions

CPAP and Non Invasive VentilationDevice

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

rapid onset of the symptoms
severe dyspnoea at rest

Sponsors & Collaborators

Ospedale S. Giovanni Bosco
Otherlead

Study Sites (1)

Ospedale San Giovanni Bosco Medicina d'Urgenza

Torino, Torino, 10154, Italy

Related Publications (1)

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.
PMID: 17908705DERIVED

MeSH Terms

Conditions

Pulmonary EdemaMyocardial Infarction

Interventions

Continuous Positive Airway PressureNoninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Giovanni Ferrari, MD
Ospedale San Giovanni Bosco ASL4 Torino Italy
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

July 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

May 2005

Actual (reported)

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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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Necrosis

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Last Updated

March 29, 2007

Record last verified: 2007-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00453947
Data provider: ClinicalTrials.gov
Source updated: 2007-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:02 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations