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Completed

NCT Number: NCT04005092

Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

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.

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Key information

Conditions

Cardiogenic Pulmonary Edema Cardiovascular Diseases Hyperemia Lung Diseases Pulmonary Edema Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hCPAP versus HFNC

Device

The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.

Primary outcomes

  1. Respiratory Rate

    Time frame: 1 hour

    Respiratory rate reduction post intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Raja Permaisuri Bainun

Other Gov

Registry information

Official study title

Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial

Acronym: HCPAPvsHFNC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2019
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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