Clinical trial NCT04005092: Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema
Official title: Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Pulmonary Edema
Keywords: non invasive ventilation
pulmonary edema
high flow nasal cannula
helmet CPAP
respiratory failure
hyperaemia
Lead sponsor: Hospital Raja Permaisuri Bainun
Sponsor class: OTHER_GOV
First posted: 2019-07-02
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Rate
timeFrame: 1 hour
Secondary outcomes:
measure: Heart Rate
timeFrame: 1 hour
measure: Partial Pressure Of Arterial Oxygen Level
timeFrame: 1 hour
measure: Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen
timeFrame: 1 hour
measure: Dyspnoea Scale
timeFrame: 1 hour
measure: Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score
timeFrame: 1 hour
measure: Rate Of Intubation
timeFrame: 1 hour
measure: 28-Days Mortality In Acute Cardiogenic Pulmonary Edema
timeFrame: 28 days
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: Emergency Department, Hospital Raja Permaisuri Bainun
state: Perak
Study officials:
affiliation: EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA
name: ADI OSMAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.