Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema (HCPAPvsHFNC)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiogenic Pulmonary Edema
• Intervention / Treatment: Device: hCPAP versus HFNC

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

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Emergency Department, Hospital Raja Permaisuri Bainun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Helmet Continuous Positive Airway Pressure(hCPAP); Helmet CPAP produce a better physiological outcomes after 1-hour intervention	Device: hCPAP versus HFNC; The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.
ACTIVE_COMPARATOR: High Flow Nasal Cannula(HFNC); HFNC produce a better physiological outcomes after 1-hour intervention	Device: hCPAP versus HFNC; The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate reduction 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 improvement post intervention	1 hour
Dyspnoea Scale	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.	1 hour
Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score	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.	1 hour
Rate Of Intubation	Intubation rate post intervention	1 hour
28-Days Mortality In Acute Cardiogenic Pulmonary Edema	Mortality due to Acute Cardiogenic Pulmonary Edema	28 days

Collaborators and Investigators

• Sponsor: Hospital Raja Permaisuri Bainun
• Investigators: Principal Investigator: ADI OSMAN, EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA

Publications and helpful links

General Publications

• Osman A, Via G, Sallehuddin RM, Ahmad AH, Fei SK, Azil A, Mojoli F, Fong CP, Tavazzi G. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1103-1111. doi: 10.1093/ehjacc/zuab078.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: respiratory failure; non invasive ventilation; high flow nasal cannula; pulmonary edema; helmet CPAP; hyperaemia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: NMRR-17-1839-36966

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