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

NCT02653365 | Completed

• 1 other identifier: BeijingCYH-ICU-002
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cardiogenic Pulmonary Edema

Outcome Measures

Primary Outcomes (10)

• 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.

• Breath frequency

  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

  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.

• 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.

• 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.

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

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

Study Arms (1)

Non-invasive ventilation

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

Device: Non-invasive ventilation

Interventions

Non-invasive ventilation DEVICE

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

Non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ACPE

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

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

Beijing, China

Location

Related Publications (1)

• Luo Z, Han F, Li Y, He H, Yang G, Mi Y, Ma Y, Cao Z. Risk factors for noninvasive ventilation failure in patients with acute cardiogenic pulmonary edema: A prospective, observational cohort study. J Crit Care. 2017 Jun;39:238-247. doi: 10.1016/j.jcrc.2017.01.001. Epub 2017 Jan 6.

  PMID: 28110770 DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 12, 2016
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

CN (1)