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

NCT ID: NCT02653365

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Cardiogenic Pulmonary Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-invasive ventilation

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

Non-invasive ventilation

Intervention Type DEVICE

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

Interventions

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Non-invasive ventilation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zujin Luo

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 28110770 (View on PubMed)

Other Identifiers

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BeijingCYH-ICU-002

Identifier Type: -

Identifier Source: org_study_id

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