Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

Overview

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.

Full Title of Study: “Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2018

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

Interventions

  • Device: hCPAP versus HFNC
    • The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.

Arms, Groups and Cohorts

  • Active Comparator: Helmet Continuous Positive Airway Pressure(hCPAP)
    • Helmet CPAP produce a better physiological outcomes after 1-hour intervention
  • Active Comparator: High Flow Nasal Cannula(HFNC)
    • HFNC produce a better physiological outcomes after 1-hour intervention

Clinical Trial Outcome Measures

Primary Measures

  • Respiratory Rate
    • Time Frame: 1 hour
    • Respiratory rate reduction post intervention

Secondary Measures

  • Heart Rate
    • Time Frame: 1 hour
    • Heart rate reduction post intervention
  • Partial Pressure Of Arterial Oxygen Level
    • Time Frame: 1 hour
    • Partial arterial oxygen level post intervention
  • Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen
    • Time Frame: 1 hour
    • Partial arterial oxygen/fraction of oxygen ratio improvement post intervention
  • 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.
  • 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.
  • Rate Of Intubation
    • Time Frame: 1 hour
    • Intubation rate post intervention
  • 28-Days Mortality In Acute Cardiogenic Pulmonary Edema
    • Time Frame: 28 days
    • Mortality due to Acute Cardiogenic Pulmonary Edema

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Raja Permaisuri Bainun
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Adi Bin Osman, EMERGENCY MEDICINE CONSULTANT – Hospital Raja Permaisuri Bainun
  • Overall Official(s)
    • ADI OSMAN, Principal Investigator, EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA

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