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Completed

NCT Number: NCT02653365

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

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.

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Key information

Conditions

Acute Cardiogenic Pulmonary Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive ventilation

Device

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

Primary outcomes

  1. Age

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

  2. Heart rate

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

  3. Blood pressure

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

  4. Breath frequency

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

  5. Arterial blood gas

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

  6. 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.

  7. 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).

  8. Left ventricular ejection fraction

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

  9. B-type natriuretic peptide

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

  10. 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.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2016
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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