Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

Not Applicable

Completed

• Conditions: Cardiogenic Pulmonary Edema
• Interventions: Device: hCPAP versus HFNC

• Registration Number: NCT04005092
• Lead Sponsor: Hospital Raja Permaisuri Bainun

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

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-30
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helmet Continuous Positive Airway Pressure(hCPAP)	hCPAP versus HFNC	Helmet CPAP produce a better physiological outcomes after 1-hour intervention
High Flow Nasal Cannula(HFNC)	hCPAP versus HFNC	HFNC produce a better physiological outcomes after 1-hour intervention

Primary Outcome Measures

Name	Time	Method
Respiratory Rate	1 hour	Respiratory rate reduction post intervention

Secondary Outcome Measures

Name	Time	Method
Heart Rate	1 hour	Heart rate reduction post intervention
Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score	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.
Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen	1 hour	Partial arterial oxygen/fraction of oxygen ratio improvement post intervention
Dyspnoea Scale	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.
Partial Pressure Of Arterial Oxygen Level	1 hour	Partial arterial oxygen level post intervention
Rate Of Intubation	1 hour	Intubation rate post intervention
28-Days Mortality In Acute Cardiogenic Pulmonary Edema	28 days	Mortality due to Acute Cardiogenic Pulmonary Edema

Trial Locations

Locations (1)

Emergency Department, Hospital Raja Permaisuri Bainun; 🇲🇾 Ipoh, Perak, Malaysia