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Completed

NCT Number: NCT04014088

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

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.

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Key information

Conditions

Acute Cardiogenic Pulmonary Edema Lung Diseases Pulmonary Edema Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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 vs fCPAP

Device

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

Primary outcomes

  1. Respiratory Rate

    Time frame: 1 hour

    Respiratory rate change post intervention

Secondary outcomes

  1. Heart Rate

    Time frame: 1 hour

    Heart rate change 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 change post intervention

  4. Dyspnea Scale

    Time frame: 1 hour

    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.

  5. Partial Pressure of Arterial Carbon Dioxide level

    Time frame: 1 hour

    Partial Pressure of Arterial Carbon Dioxide level change post intervention.

  6. Rate of Intubation

    Time frame: 1 hour

    Intubation rate post intervention

Sponsors and collaborators

Lead sponsor

Hospital Raja Permaisuri Bainun

Other Gov

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 10, 2019
Registry last updated
Mar 17, 2025

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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