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

Acute Cardiogenic Pulmonary Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014088
• Other study ID #: NMRR-14-1894-21782 (IIR).
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 10, 2018

Study information

• Verified date: July 2019
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 10, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• 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

• Acute Cardiogenic Pulmonary Edema
• Edema
• Pulmonary Edema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Raja Permaisuri Bainun

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Rate	Respiratory rate change post intervention	1 hour
Secondary	Heart Rate	Heart rate change 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 change post intervention	1 hour
Secondary	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
Secondary	Partial Pressure of Arterial Carbon Dioxide level	Partial Pressure of Arterial Carbon Dioxide level change post intervention.	1 hour
Secondary	Rate of Intubation	Intubation rate post intervention	1 hour