Clinical trial NCT02653365: Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cardiogenic Pulmonary Edema
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ACPE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Age
timeFrame: From study entry to death or intensive care unit (ICU) discharge, up to 3 years.
measure: Heart rate
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: Blood pressure
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: Breath frequency
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: Arterial blood gas
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: New York Heart Association classification
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: Killip classification
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: Left ventricular ejection fraction
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: B-type natriuretic peptide
timeFrame: From study entry to death or ICU discharge, up to 3 years.
measure: Fluid balance within 24 hours after presence of acute cardiogenic pulmonary edema.
timeFrame: From study entry to death or ICU discharge, up to 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Study officials:
References:
citation: 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.