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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02653365
Enrollment
118
Registered
2016-01-12
Start date
2012-03-31
Completion date
2015-04-30
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cardiogenic Pulmonary Edema

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.

Interventions

DEVICENon-invasive ventilation

Noninvasive ventilation (NIV) was performed with a noninvasive ventilator (BiPAP Synchrony®, Respironics Inc., Murrysville, PA, USA).

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
AgeFrom study entry to death or intensive care unit (ICU) discharge, up to 3 years.
Heart rateFrom study entry to death or ICU discharge, up to 3 years.
Blood pressureFrom study entry to death or ICU discharge, up to 3 years.
Breath frequencyFrom study entry to death or ICU discharge, up to 3 years.
Arterial blood gasFrom study entry to death or ICU discharge, up to 3 years.
New York Heart Association classificationFrom 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 classificationFrom 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 fractionFrom study entry to death or ICU discharge, up to 3 years.
B-type natriuretic peptideFrom study entry to death or ICU discharge, up to 3 years.
Fluid balance within 24 hours after presence of acute cardiogenic pulmonary edema.From study entry to death or ICU discharge, up to 3 years.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026