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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Cardiogenic Pulmonary Edema
• Intervention / Treatment: Device: hCPAP vs 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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: helmet CPAP; helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema	Device: hCPAP vs fCPAP; The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.
Active Comparator: facemask CPAP; facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema	Device: hCPAP vs fCPAP; The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Rate	Respiratory rate change post intervention	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate change post intervention	1 hour
Partial Pressure of Arterial Oxygen Level	Partial arterial oxygen level post intervention	1 hour
Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen	Partial arterial oxygen/fraction of oxygen ratio change post intervention	1 hour
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.	1 hour
Partial Pressure of Arterial Carbon Dioxide level	Partial Pressure of Arterial Carbon Dioxide level change post intervention.	1 hour
Rate of Intubation	Intubation rate post intervention	1 hour

Collaborators and Investigators

• Sponsor: Hospital Raja Permaisuri Bainun
• Investigators: Principal Investigator: Adi Osman, Emergency Department, Hospital Raja Permaisuri Bainun

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: non invasive ventilation; pulmonary edema; helmet CPAP; facemask CPAP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Edema; Edema
• Other Study ID Numbers: NMRR-14-1894-21782 (IIR).

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No