Acute Cardiogenic Pulmonary EdemaNCT02653365
Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema
An observational study of Acute Cardiogenic Pulmonary Edema, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cardiogenic Pulmonary Edema
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ACPE
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Beijing
About this study
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
- Being tested
- Non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationDevice
Noninvasive ventilation (NIV) was performed with a noninvasive ventilator (BiPAP Synchrony®, Respironics Inc., Murrysville, PA, USA).
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive ventilation | All patients eligible for inclusion in the study were treated with Non-invasive ventilation. Receives: Device: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Measured: From study entry to death or intensive care unit (ICU) discharge, up to 3 years.
Heart rate
Measured: From study entry to death or ICU discharge, up to 3 years.
Blood pressure
Measured: From study entry to death or ICU discharge, up to 3 years.
Breath frequency
Measured: From study entry to death or ICU discharge, up to 3 years.
Arterial blood gas
Measured: 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.
Measured: 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).
Measured: From study entry to death or ICU discharge, up to 3 years.
Left ventricular ejection fraction
Measured: From study entry to death or ICU discharge, up to 3 years.
B-type natriuretic peptide
Measured: From study entry to death or ICU discharge, up to 3 years.
Fluid balance within 24 hours after presence of acute cardiogenic pulmonary edema.
Measured: From study entry to death or ICU discharge, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Cardiogenic Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zujin Luo, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653365
- Sponsor's protocol ID
- BeijingCYH-ICU-002
- Status last verified
- Jan 2016
- First submitted
- 24 Dec 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
Publications
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.
PubMed 28110770
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema
- ClinicalTrials.gov ID
- NCT02653365
- Acronym / sponsor ID
- BeijingCYH-ICU-002
- Conditions
- Acute Cardiogenic Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive ventilation | – | Device: Non-invasive ventilationAll patients eligible for inclusion in the study were treated with Non-invasive ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ACPE
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilationNoninvasive ventilation (NIV) was performed with a noninvasive ventilator (BiPAP Synchrony®, Respironics Inc., Murrysville, PA, USA). | Device | Non-invasive ventilation |
Primary outcome
Age
Time frame: From study entry to death or intensive care unit (ICU) discharge, up to 3 years.
Heart rate
Time frame: From study entry to death or ICU discharge, up to 3 years.
Blood pressure
Time frame: From study entry to death or ICU discharge, up to 3 years.
Breath frequency
Time frame: From study entry to death or ICU discharge, up to 3 years.
Arterial blood gas
Time frame: From study entry to death or ICU discharge, up to 3 years.
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.
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).
Left ventricular ejection fraction
Time frame: From study entry to death or ICU discharge, up to 3 years.
B-type natriuretic peptide
Time frame: From study entry to death or ICU discharge, up to 3 years.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 28110770Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cardiogenic Pulmonary Edema, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: From study entry to death or intensive care unit (ICU) discharge, up to 3 years.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.