Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

Cardiogenic Pulmonary Edema Clinical Trial

— HCPAPvsHFNC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005092
• Other study ID #: NMRR-17-1839-36966
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2021
• Source: Hospital Raja Permaisuri Bainun
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: September 30, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Pulmonary Edema
• Edema
• Pulmonary Edema

Intervention

Device:
• hCPAP versus HFNC
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.

Locations

Country	Name	City	State
Malaysia	Emergency Department, Hospital Raja Permaisuri Bainun	Ipoh	Perak

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Raja Permaisuri Bainun

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Rate	Respiratory rate reduction post intervention	1 hour
Secondary	Heart Rate	Heart rate reduction post intervention	1 hour
Secondary	Partial Pressure Of Arterial Oxygen Level	Partial arterial oxygen level post intervention	1 hour
Secondary	Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen	Partial arterial oxygen/fraction of oxygen ratio improvement post intervention	1 hour
Secondary	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
Secondary	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
Secondary	Rate Of Intubation	Intubation rate post intervention	1 hour
Secondary	28-Days Mortality In Acute Cardiogenic Pulmonary Edema	Mortality due to Acute Cardiogenic Pulmonary Edema	28 days