RecruitingInterventionalNot ApplicableUpdated Aug 15, 2025
Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema | NCT02653365 | Trialant
CompletedObservationalUpdated Jan 13, 2016
Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema
ClinicalTrials.gov ID
NCT02653365
Lead Sponsor
Beijing Chao Yang HospitalOTHER
Overall Status
Completed
Study Type
Observational
Enrollment
118Actual
Last Update Posted
Jan 13, 2016Estimated
Start Date
Mar 2012
Primary Completion Date
Mar 2015Actual
Completion Date
Apr 2015Actual
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.
Acute Cardiogenic Pulmonary Edema
Non-invasive ventilation
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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.
Observational Model
Cohort
Time Perspective
Prospective
No central contacts
There are no central contacts for this study.
Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University