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Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema (HCPAPvsHFNC)

Primary Purpose

Cardiogenic Pulmonary Edema

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

hCPAP versus HFNC

About this trial

This is an interventional treatment trial for Cardiogenic Pulmonary Edema focused on measuring non invasive ventilation, pulmonary edema, high flow nasal cannula, helmet CPAP, respiratory failure, hyperaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema.

Exclusion Criteria:

Age less than 18 years old
Low GCS (less than 8), altered mental status
Hemodynamic instability, impending cardiopulmonary arrest
Use of vasopressors, inotropes
Exacerbation of asthma or chronic respiratory failure
Urgent need for endotracheal intubation
Absence of airway protective gag reflex
Elevated intracranial pressure
Tracheostomy
Pregnant
Upper airway obstruction
Injuries or surgery to head and neck less than 6 months upon presentation
Claustrophobia
Blind or poor vision
Medico-legal related cases

Sites / Locations

Emergency Department, Hospital Raja Permaisuri Bainun

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Helmet Continuous Positive Airway Pressure(hCPAP)

High Flow Nasal Cannula(HFNC)

Arm Description

Helmet CPAP produce a better physiological outcomes after 1-hour intervention

HFNC produce a better physiological outcomes after 1-hour intervention

Outcomes

Primary Outcome Measures

Respiratory Rate

Respiratory rate reduction post intervention

Secondary Outcome Measures

Heart Rate

Heart rate reduction post intervention

Partial Pressure Of Arterial Oxygen Level

Partial arterial oxygen level post intervention

Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen

Partial arterial oxygen/fraction of oxygen ratio improvement post intervention

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.

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.

Rate Of Intubation

Intubation rate post intervention

28-Days Mortality In Acute Cardiogenic Pulmonary Edema

Mortality due to Acute Cardiogenic Pulmonary Edema

Full Information

NCT ID

NCT04005092

First Posted

June 27, 2019

Last Updated

January 18, 2021

Sponsor

Hospital Raja Permaisuri Bainun

1. Study Identification

Unique Protocol Identification Number

NCT04005092

Brief Title

Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

Acronym

HCPAPvsHFNC

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

August 31, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Raja Permaisuri Bainun

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiogenic Pulmonary Edema

Keywords

non invasive ventilation, pulmonary edema, high flow nasal cannula, helmet CPAP, respiratory failure, hyperaemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Helmet Continuous Positive Airway Pressure(hCPAP)

Arm Type

Active Comparator

Arm Description

Helmet CPAP produce a better physiological outcomes after 1-hour intervention

Arm Title

High Flow Nasal Cannula(HFNC)

Arm Type

Active Comparator

Arm Description

HFNC produce a better physiological outcomes after 1-hour intervention

Intervention Type

Device

Intervention Name(s)

hCPAP versus HFNC

Intervention Description

The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.

Primary Outcome Measure Information:

Title

Respiratory Rate

Description

Respiratory rate reduction post intervention

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Heart Rate

Description

Heart rate reduction post intervention

Time Frame

1 hour

Title

Partial Pressure Of Arterial Oxygen Level

Description

Partial arterial oxygen level post intervention

Time Frame

1 hour

Title

Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen

Description

Partial arterial oxygen/fraction of oxygen ratio improvement post intervention

Time Frame

1 hour

Title

Dyspnoea Scale

Description

Time Frame

1 hour

Title

Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score

Description

Time Frame

1 hour

Title

Rate Of Intubation

Description

Intubation rate post intervention

Time Frame

1 hour

Title

28-Days Mortality In Acute Cardiogenic Pulmonary Edema

Description

Mortality due to Acute Cardiogenic Pulmonary Edema

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema. Exclusion Criteria: Age less than 18 years old Low GCS (less than 8), altered mental status Hemodynamic instability, impending cardiopulmonary arrest Use of vasopressors, inotropes Exacerbation of asthma or chronic respiratory failure Urgent need for endotracheal intubation Absence of airway protective gag reflex Elevated intracranial pressure Tracheostomy Pregnant Upper airway obstruction Injuries or surgery to head and neck less than 6 months upon presentation Claustrophobia Blind or poor vision Medico-legal related cases

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ADI OSMAN

Organizational Affiliation

EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emergency Department, Hospital Raja Permaisuri Bainun

City

Ipoh

State/Province

Perak

ZIP/Postal Code

30450

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34632507

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.

Results Reference

derived

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Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

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