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Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema (HCPAPvsHFNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005092
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Adi Bin Osman, Hospital Raja Permaisuri Bainun

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiogenic Pulmonary Edema Device: hCPAP versus HFNC Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Helmet Continuous Positive Airway Pressure(hCPAP)
Helmet CPAP produce a better physiological outcomes after 1-hour intervention
Device: hCPAP versus HFNC
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.

Active Comparator: High Flow Nasal Cannula(HFNC)
HFNC produce a better physiological outcomes after 1-hour intervention
Device: hCPAP versus HFNC
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.




Primary Outcome Measures :
  1. Respiratory Rate [ Time Frame: 1 hour ]
    Respiratory rate reduction post intervention


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: 1 hour ]
    Heart rate reduction post intervention

  2. Partial Pressure Of Arterial Oxygen Level [ Time Frame: 1 hour ]
    Partial arterial oxygen level post intervention

  3. Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen [ Time Frame: 1 hour ]
    Partial arterial oxygen/fraction of oxygen ratio improvement post intervention

  4. Dyspnoea Scale [ Time Frame: 1 hour ]
    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.

  5. Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score [ Time Frame: 1 hour ]
    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.

  6. Rate Of Intubation [ Time Frame: 1 hour ]
    Intubation rate post intervention

  7. 28-Days Mortality In Acute Cardiogenic Pulmonary Edema [ Time Frame: 28 days ]
    Mortality due to Acute Cardiogenic Pulmonary Edema



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema.

Exclusion Criteria:

  1. Age less than 18 years old
  2. Low GCS (less than 8), altered mental status
  3. Hemodynamic instability, impending cardiopulmonary arrest
  4. Use of vasopressors, inotropes
  5. Exacerbation of asthma or chronic respiratory failure
  6. Urgent need for endotracheal intubation
  7. Absence of airway protective gag reflex
  8. Elevated intracranial pressure
  9. Tracheostomy
  10. Pregnant
  11. Upper airway obstruction
  12. Injuries or surgery to head and neck less than 6 months upon presentation
  13. Claustrophobia
  14. Blind or poor vision
  15. Medico-legal related cases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005092


Locations
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Malaysia
Emergency Department, Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia, 30450
Sponsors and Collaborators
Hospital Raja Permaisuri Bainun
Investigators
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Principal Investigator: ADI OSMAN EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA
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Responsible Party: Dr. Adi Bin Osman, EMERGENCY MEDICINE CONSULTANT, Hospital Raja Permaisuri Bainun
ClinicalTrials.gov Identifier: NCT04005092    
Other Study ID Numbers: NMRR-17-1839-36966
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Adi Bin Osman, Hospital Raja Permaisuri Bainun:
non invasive ventilation
pulmonary edema
high flow nasal cannula
helmet CPAP
respiratory failure
hyperaemia
Additional relevant MeSH terms:
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Pulmonary Edema
Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases