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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04005092
Other study ID # NMRR-17-1839-36966
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A
Completed NCT00785174 - Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study Phase 3
Recruiting NCT06107257 - Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
Completed NCT03041428 - Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO) N/A
Completed NCT00390442 - Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema Phase 3