search
Back to results

Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)

Primary Purpose

Acute Cardiogenic Pulmonary Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hCPAP vs fCPAP
Sponsored by
Hospital Raja Permaisuri Bainun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cardiogenic Pulmonary Edema focused on measuring helmet CPAP, facemask CPAP, pulmonary edema, non invasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    helmet CPAP

    facemask CPAP

    Arm Description

    helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema

    facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema

    Outcomes

    Primary Outcome Measures

    Respiratory Rate
    Respiratory rate change post intervention

    Secondary Outcome Measures

    Heart Rate
    Heart rate change post intervention
    Partial Pressure of Arterial Oxygen Level
    Partial arterial oxygen level post intervention
    Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen
    Partial arterial oxygen/fraction of oxygen ratio change post intervention
    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.
    Partial Pressure of Arterial Carbon Dioxide level
    Partial Pressure of Arterial Carbon Dioxide level change post intervention.
    Rate of Intubation
    Intubation rate post intervention

    Full Information

    First Posted
    July 4, 2019
    Last Updated
    July 12, 2019
    Sponsor
    Hospital Raja Permaisuri Bainun
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04014088
    Brief Title
    Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    January 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Raja Permaisuri Bainun

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Cardiogenic Pulmonary Edema
    Keywords
    helmet CPAP, facemask CPAP, pulmonary edema, non invasive ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    164 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    helmet CPAP
    Arm Type
    Active Comparator
    Arm Description
    helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema
    Arm Title
    facemask CPAP
    Arm Type
    Active Comparator
    Arm Description
    facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema
    Intervention Type
    Device
    Intervention Name(s)
    hCPAP vs fCPAP
    Intervention Description
    The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.
    Primary Outcome Measure Information:
    Title
    Respiratory Rate
    Description
    Respiratory rate change post intervention
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Heart Rate
    Description
    Heart rate change post intervention
    Time Frame
    1 hour
    Title
    Partial Pressure of Arterial Oxygen Level
    Description
    Partial arterial oxygen level post intervention
    Time Frame
    1 hour
    Title
    Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen
    Description
    Partial arterial oxygen/fraction of oxygen ratio change post intervention
    Time Frame
    1 hour
    Title
    Dyspnea Scale
    Description
    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.
    Time Frame
    1 hour
    Title
    Partial Pressure of Arterial Carbon Dioxide level
    Description
    Partial Pressure of Arterial Carbon Dioxide level change post intervention.
    Time Frame
    1 hour
    Title
    Rate of Intubation
    Description
    Intubation rate post intervention
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema Exclusion Criteria: 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adi Osman
    Organizational Affiliation
    Emergency Department, Hospital Raja Permaisuri Bainun
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)

    We'll reach out to this number within 24 hrs