Acute Cardiogenic Pulmonary EdemaNCT04014088
Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)
A study testing hCPAP vs fCPAP in people with Acute Cardiogenic Pulmonary Edema, run by Hospital Raja Permaisuri Bainun.
Trial summary
This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Cardiogenic Pulmonary Edema
- What is being tested?
- hCPAP vs fCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 10 Jan 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 to 100 years
- All sexes
- No healthy volunteers
- 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
About this study
Official title: A Randomized Controlled Trial Comparing Helmet Continuous Positive Airway Pressure (CPAP) vs Facemask CPAP for Treatment of Acute Cardiogenic Pulmonary Edema In The Emergency Department
This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP.
Read the detailed description
Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute cardiogenic pulmonary edema. The appropriate interface is necessary to provide comfort and lead to the success of NIV.
NIV delivered via facemask had been used widely. However, it was associated with leaks and discomfort to the patient.
Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.
- Conditions
- Acute Cardiogenic Pulmonary Edema
- Being tested
- hCPAP vs fCPAP
- Keywords
- helmet CPAP, facemask CPAP, pulmonary edema, non invasive ventilation
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCPAP vs fCPAPDevice
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.
| Study group | Role | What they receive |
|---|---|---|
| helmet CPAP | Active comparator | helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema Receives: Device: hCPAP vs fCPAP |
| facemask CPAP | Active comparator | facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema Receives: Device: hCPAP vs fCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate
Respiratory rate change post intervention
Measured: 1 hour
Secondary outcomes (6)
Heart Rate
Heart rate change 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 change post intervention
Measured: 1 hour
Dyspnea Scale
Dyspnea scale improvement post intervention.Dyspnea scale measured using an unmarked 100mm 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 "100" represent the worst difficulty perceived by patients.
Measured: 1 hour
Partial Pressure of Arterial Carbon Dioxide level
Partial Pressure of Arterial Carbon Dioxide level change post intervention.
Measured: 1 hour
Rate of Intubation
Intubation rate post intervention
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 164 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014088
- Sponsor's protocol ID
- NMRR-14-1894-21782 (IIR).
- Status last verified
- Mar 2025
- First submitted
- 4 Jul 2019
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Helmet Continuous Positive Airway Pressure (CPAP) vs Facemask CPAP for Treatment of Acute Cardiogenic Pulmonary Edema In The Emergency Department
- ClinicalTrials.gov ID
- NCT04014088
- Acronym / sponsor ID
- NMRR-14-1894-21782 (IIR).
- Conditions
- Acute Cardiogenic Pulmonary Edema
- Keywords
- helmet CPAP, facemask CPAP, pulmonary edema, non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Hospital Raja Permaisuri BainunOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 10 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 Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP.
Detailed description
Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute cardiogenic pulmonary edema. The appropriate interface is necessary to provide comfort and lead to the success of NIV.
NIV delivered via facemask had been used widely. However, it was associated with leaks and discomfort to the patient.
Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| helmet CPAP | Active comparator | Device: hCPAP vs fCPAPhelmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema |
| facemask CPAP | Active comparator | Device: hCPAP vs fCPAPfacemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not 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 vs fCPAPThe patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP. | Device | facemask CPAP, helmet CPAP |
Primary outcome
Respiratory Rate
Time frame: 1 hour
Respiratory rate change post intervention
6 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
Dyspnea Scale
Time frame: 1 hour
Partial Pressure of Arterial Carbon Dioxide level
Time frame: 1 hour
Rate of Intubation
Time frame: 1 hour
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 17 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Cardiogenic Pulmonary Edema
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
Questions about this trial
What is this clinical trial studying?
A study testing hCPAP vs fCPAP in people with Acute Cardiogenic Pulmonary Edema, run by Hospital Raja Permaisuri Bainun.
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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 17 Mar 2025.