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Clinical Trials/NCT02653365
NCT02653365
Completed
Not Applicable

Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema

Beijing Chao Yang Hospital1 site in 1 country118 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Cardiogenic Pulmonary Edema
Sponsor
Beijing Chao Yang Hospital
Enrollment
118
Locations
1
Primary Endpoint
Heart rate
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The aims of our study was to identify early predictors of non-invasive ventilation failure, so as to alert clinicians early that endotracheal intubation and mechanical ventilation might be appropriate.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
April 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Chao Yang Hospital
Responsible Party
Principal Investigator
Principal Investigator

Zujin Luo

Attending physician

Beijing Chao Yang Hospital

Eligibility Criteria

Inclusion Criteria

  • Presence of ACPE diagnosed based on SpO2 below 90% with \>5 L/ min oxygen via reservoir face mask
  • Acute respiratory distress as evidenced by severe dyspnea
  • Breathing frequency of \>30 breaths/min, and use of accessory respiratory muscles or paradoxical abdominal motion in association with tachycardia
  • Cardiac gallops, bilateral rales, and typical findings of congestion on chest radiography, without a history suggesting pulmonary aspiration or evidence of pneumonia.

Exclusion Criteria

  • Patients were excluded from the study if they were intubated before ICU admission, or required immediate intubation without prior NIV, or presented a respiratory or cardiac arrest
  • Severe hemodynamic instability (systolic arterial pressure \<70 mmHg despite adequate fluid repletion and use of vasoactive agents) or life-threatening ventricular arrhythmias.
  • Patients were also excluded if they were unresponsive, agitated, and unable to cooperate; or if they had any condition that precluded application of a face mask including upper airway obstruction
  • Recent oral or facial trauma or surgery
  • Recent gastric or esophageal surgery
  • Inability to clear respiratory secretions or high risk for aspiration.
  • In addition, patients were excluded if they had a "do not intubate" order or refused research authorization.

Outcomes

Primary Outcomes

Heart rate

Time Frame: From study entry to death or ICU discharge, up to 3 years.

Breath frequency

Time Frame: From study entry to death or ICU discharge, up to 3 years.

Fluid balance within 24 hours after presence of acute cardiogenic pulmonary edema.

Time Frame: From study entry to death or ICU discharge, up to 3 years.

Age

Time Frame: From study entry to death or intensive care unit (ICU) discharge, up to 3 years.

Blood pressure

Time Frame: From study entry to death or ICU discharge, up to 3 years.

Arterial blood gas

Time Frame: From study entry to death or ICU discharge, up to 3 years.

New York Heart Association classification

Time Frame: From study entry to death or ICU discharge, up to 3 years.

The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Killip classification

Time Frame: From study entry to death or ICU discharge, up to 3 years.

The Killip classification is a system used in individuals with an acute myocardial infarction, in order to risk stratify them. Patients were ranked by Killip class in the following way: Killip class I includes individuals with no clinical signs of heart failure. Killip class II includes individuals with rales or crackles in the lungs, an S3, and elevated jugular venous pressure. Killip class III describes individuals with frank acute pulmonary edema. Killip class IV describes individuals in cardiogenic shock or hypotension (measured as systolic blood pressure lower than 90 mmHg), and evidence of peripheral vasoconstriction (oliguria, cyanosis or sweating).

Left ventricular ejection fraction

Time Frame: From study entry to death or ICU discharge, up to 3 years.

B-type natriuretic peptide

Time Frame: From study entry to death or ICU discharge, up to 3 years.

Study Sites (1)

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