Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Brief Summary

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The purpose of this study is to define the current treatment of patients ospitalized with acute cardiogenic pulmonary edema. Clinical and laboratory data collected in the Emergency Department will used to investigate the primary outcome (mortality) and risk factors related to the primary outcome.

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Detailed Description

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ACPE is a common cause of presentation to the Emergency Department (ED). Early recognition of high-risk patients could help in better locating human and technical resources and in deciding adequate treatment and site of care.

The investigators planned a real life, multicentric, prospective, web-based observational study performed in Italian Emergency Departments.

The investigators enroll consecutive patients admitted to the Emergency Department with acute cardiogenic pulmonary edema, that is defined as all the following: respiratory distress, bilateral rales and congestion on chest X-ray.

Demographic, clinical and laboratory findings are collected on admission and during hospitalization to evaluate mortality and risk factors related to mortality.

Conditions

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Pulmonary Edema Respiratory Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acute cardiogenic pulmonary edema

Non invasive ventilation

Intervention Type DEVICE

Indications for the use of NIV are at least one of the following:

* Respiratory Rate ≥ 30 bpm
* PaO2/FiO2 \< 200
* pH \< 7.35 and PaCO2 \> 45 mmH

Contraindications for the use of NIV are at least one of the following:

* Coma
* Hemodynamic instability / shock
* Lack of compliance

Indications for endotracheal intubation (ETI) are at least one of the following:

* Respiratory or cardiac arrest
* Coma
* Hemodynamic instability

Interventions

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Non invasive ventilation

Indications for the use of NIV are at least one of the following:

* Respiratory Rate ≥ 30 bpm
* PaO2/FiO2 \< 200
* pH \< 7.35 and PaCO2 \> 45 mmH

Contraindications for the use of NIV are at least one of the following:

* Coma
* Hemodynamic instability / shock
* Lack of compliance

Indications for endotracheal intubation (ETI) are at least one of the following:

* Respiratory or cardiac arrest
* Coma
* Hemodynamic instability

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

all of the following:

* age ≥ 18
* acute-onset dyspnea
* widespread pulmonary rales
* pulmonary congestion on chest X- ray plus one of the following:
* respiratory distress
* respiratory rate ≥ 30
* emogasanalysis: pH \< 7.35 and pCO2 \> 45 mmHg in Venturi-Mask 50%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No