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

Completed

• Conditions: Acute Cardiogenic Pulmonary Edema
• Interventions: Device: Non-invasive ventilation

• Registration Number: NCT02653365
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Study First Submitted: 2015-12-24
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-09
• Study First Posted: 2016-01-12
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-invasive ventilation	Non-invasive ventilation	All patients eligible for inclusion in the study were treated with Non-invasive ventilation.

Primary Outcome Measures

Name	Time	Method
Breath frequency	From 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.
Age	From study entry to death or intensive care unit (ICU) discharge, up to 3 years.
Heart rate	From study entry to death or ICU discharge, up to 3 years.
Blood pressure	From study entry to death or ICU discharge, up to 3 years.
Arterial blood gas	From study entry to death or ICU discharge, up to 3 years.
New York Heart Association classification	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	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	From study entry to death or ICU discharge, up to 3 years.
B-type natriuretic peptide	From study entry to death or ICU discharge, up to 3 years.

Trial Locations

Locations (1)

Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University; 🇨🇳 Beijing, China