Cardiogenic Pulmonary EdemaHCPAPvsHFNCNCT04005092
Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema
A study testing hCPAP versus HFNC in people with Cardiogenic Pulmonary Edema, run by Hospital Raja Permaisuri Bainun at 1 site in Malaysia.
Trial summary
This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Oedema (ACPE) patients in the Emergency Department (ED) delivered by Helmet CPAP (hCPAP) and HFNC.Patients will be randomized to receive either hCPAP or HFNC. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiogenic Pulmonary Edema
- What is being tested?
- hCPAP versus HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2018to 30 Sep 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema.
Who cannot join
- Age less than 18 years old
- Low GCS (less than 8), altered mental status
- Hemodynamic instability, impending cardiopulmonary arrest
- Use of vasopressors, inotropes
- Exacerbation of asthma or chronic respiratory failure
- Urgent need for endotracheal intubation
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- Absence of airway protective gag reflex
- Elevated intracranial pressure
- Tracheostomy
- Pregnant
- Upper airway obstruction
- Injuries or surgery to head and neck less than 6 months upon presentation
- Claustrophobia
- Blind or poor vision
- Medico-legal related cases
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Emergency Department, Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450
About this study
Official title: Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial
This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Oedema (ACPE) patients in the Emergency Department (ED) delivered by Helmet CPAP (hCPAP) and HFNC.Patients will be randomized to receive either hCPAP or HFNC.
Read the detailed description
Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute hypoxaemic and hypercapnic respiratory failure. The appropriate interface is necessary to provide comfort and lead to the success of NIV.
Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.
HFNC which delivers heated humidified high flow oxygen provides a good alternative to the conventional NIV in terms of comfort
- Conditions
- Cardiogenic Pulmonary Edema
- Being tested
- hCPAP versus HFNC
- Keywords
- non invasive ventilation, pulmonary edema, high flow nasal cannula, helmet CPAP, respiratory failure, hyperaemia
- Medical subject headings
- Pulmonary Edema, Respiratory Insufficiency, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCPAP versus HFNCDevice
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.
| Study group | Role | What they receive |
|---|---|---|
| Helmet Continuous Positive Airway Pressure(hCPAP) | Active comparator | Helmet CPAP produce a better physiological outcomes after 1-hour intervention Receives: Device: hCPAP versus HFNC |
| High Flow Nasal Cannula(HFNC) | Active comparator | HFNC produce a better physiological outcomes after 1-hour intervention Receives: Device: hCPAP versus HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate
Respiratory rate reduction post intervention
Measured: 1 hour
Secondary outcomes (7)
Heart Rate
Heart rate reduction post intervention
Measured: 1 hour
Partial Pressure Of Arterial Oxygen Level
Partial arterial oxygen level post intervention
Measured: 1 hour
Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen
Partial arterial oxygen/fraction of oxygen ratio improvement post intervention
Measured: 1 hour
Dyspnoea Scale
Dyspnoea scale improvement post intervention.Dyspnea scale measured using an unmarked 10cm VAS card that had mark with "I can breathe normally", at one end correspond to patients' normal baseline breathing which score "0" and on the other end "I can't breathe at all", which score "10" represent the worst difficulty perceived by patients.
Measured: 1 hour
Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score
Heart rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) and Respiratory rate(HACOR) Score improvement post intervention.HACOR is an acronym for heart rate, acidosis (pH), consciousness (GCS), oxygenation (PF ratio) and respiratory rate in which each parameter is an independent predictor for NIV failure. HACOR score is out of 25 with differential weighting of each parameter.
Measured: 1 hour
Rate Of Intubation
Intubation rate post intervention
Measured: 1 hour
28-Days Mortality In Acute Cardiogenic Pulmonary Edema
Mortality due to Acute Cardiogenic Pulmonary Edema
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jan 2018
- Primary completion31 Aug 2018
- Study completion30 Sep 2018
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 Cardiogenic Pulmonary EdemaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Raja Permaisuri Bainun
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Adi Bin Osman, Hospital Raja Permaisuri Bainun
- Investigators
- ADI OSMAN, Principal investigator, EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005092
- Sponsor's protocol ID
- NMRR-17-1839-36966
- Acronym
- HCPAPvsHFNC
- Status last verified
- Jan 2021
- First submitted
- 27 Jun 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osman A, Via G, Sallehuddin RM, Ahmad AH, Fei SK, Azil A, Mojoli F, Fong CP, Tavazzi G. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1103-1111. doi: 10.1093/ehjacc/zuab078.
PubMed 34632507
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04005092
- Acronym / sponsor ID
- HCPAPvsHFNC / NMRR-17-1839-36966
- Conditions
- Cardiogenic Pulmonary Edema
- Keywords
- non invasive ventilation, pulmonary edema, high flow nasal cannula, helmet CPAP, respiratory failure, hyperaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Hospital Raja Permaisuri BainunOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 2 Jul 2019 (actual)
- 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.
This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Oedema (ACPE) patients in the Emergency Department (ED) delivered by Helmet CPAP (hCPAP) and HFNC.Patients will be randomized to receive either hCPAP or HFNC.
Detailed description
Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute hypoxaemic and hypercapnic respiratory failure. The appropriate interface is necessary to provide comfort and lead to the success of NIV.
Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.
HFNC which delivers heated humidified high flow oxygen provides a good alternative to the conventional NIV in terms of comfort
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helmet Continuous Positive Airway Pressure(hCPAP) | Active comparator | Device: hCPAP versus HFNCHelmet CPAP produce a better physiological outcomes after 1-hour intervention |
| High Flow Nasal Cannula(HFNC) | Active comparator | Device: hCPAP versus HFNCHFNC produce a better physiological outcomes after 1-hour intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema.
Key exclusion criteria (15 listed)
- Age less than 18 years old
- Low GCS (less than 8), altered mental status
- Hemodynamic instability, impending cardiopulmonary arrest
- Use of vasopressors, inotropes
- Exacerbation of asthma or chronic respiratory failure
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 |
|---|---|---|
| hCPAP versus HFNCThe patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC. | Device | Helmet Continuous Positive Airway Pressure(hCPAP), High Flow Nasal Cannula(HFNC) |
Primary outcome
Respiratory Rate
Time frame: 1 hour
Respiratory rate reduction post intervention
7 secondary outcomes
Heart Rate
Time frame: 1 hour
Partial Pressure Of Arterial Oxygen Level
Time frame: 1 hour
Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen
Time frame: 1 hour
Dyspnoea Scale
Time frame: 1 hour
Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score
Time frame: 1 hour
Rate Of Intubation
Time frame: 1 hour
28-Days Mortality In Acute Cardiogenic Pulmonary Edema
Time frame: 28 days
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 22 Jan 2021.
- Derived from this study: PubMed 34632507Osman A, Via G, Sallehuddin RM, Ahmad AH, Fei SK, Azil A, Mojoli F, Fong CP, Tavazzi G. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1103-1111. doi: 10.1093/ehjacc/zuab078.
- Individual participant dataSharing planned: No
Related trials for Cardiogenic Pulmonary Edema
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Recruiting
COMPARE-VENT Feasibility Pilot Study
Respiration Failure, Cardio Vascular Disease
Recruiting
HF vs NIV in Acute Cardiogenic Pulmonary Edema
Pulmonary Edema Cardiac Cause
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.
ADI OSMAN principal investigator
EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hCPAP versus HFNC in people with Cardiogenic Pulmonary Edema, run by Hospital Raja Permaisuri Bainun at 1 site in Malaysia.
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 1 inclusion and 15 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 22 Jan 2021. 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 Malaysia. 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?
Respiratory Rate (time frame: 1 hour). 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 NCT04005092, 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 22 Jan 2021.