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

Acute Cardiogenic Pulmonary Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653365
• Other study ID #: BeijingCYH-ICU-002
• Status: Completed
• Phase: N/A
• First received: December 24, 2015
• Last updated: January 12, 2016
• Start date: March 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Cardiogenic Pulmonary Edema
• Pulmonary Edema

Intervention

Device:
• Non-invasive ventilation
Noninvasive ventilation (NIV) was performed with a noninvasive ventilator (BiPAP Synchrony®, Respironics Inc., Murrysville, PA, USA).

Locations

Country	Name	City	State
China	Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age		From study entry to death or intensive care unit (ICU) discharge, up to 3 years.	No
Primary	Heart rate		From study entry to death or ICU discharge, up to 3 years.
Primary	Blood pressure		From study entry to death or ICU discharge, up to 3 years.
Primary	Breath frequency		From study entry to death or ICU discharge, up to 3 years.
Primary	Arterial blood gas		From study entry to death or ICU discharge, up to 3 years.
Primary	New York Heart Association classification	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.	From study entry to death or ICU discharge, up to 3 years.
Primary	Killip classification	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).	From study entry to death or ICU discharge, up to 3 years.
Primary	Left ventricular ejection fraction		From study entry to death or ICU discharge, up to 3 years.
Primary	B-type natriuretic peptide		From study entry to death or ICU discharge, up to 3 years.
Primary	Fluid balance within 24 hours after presence of acute cardiogenic pulmonary edema.		From study entry to death or ICU discharge, up to 3 years.