NCT04005092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

June 27, 2019

Last Update Submit

January 18, 2021

Conditions

Cardiogenic Pulmonary Edema

Keywords

non invasive ventilationpulmonary edemahigh flow nasal cannulahelmet CPAPrespiratory failurehyperaemia

Outcome Measures

Primary Outcomes (1)

  • Respiratory Rate

    Respiratory rate reduction post intervention

    1 hour

Secondary Outcomes (7)

  • Heart Rate

    1 hour

  • Partial Pressure Of Arterial Oxygen Level

    1 hour

  • Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen

    1 hour

  • Dyspnoea Scale

    1 hour

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

    1 hour

  • +2 more secondary outcomes

Study Arms (2)

Helmet Continuous Positive Airway Pressure(hCPAP)

ACTIVE COMPARATOR

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

Device: hCPAP versus HFNC

High Flow Nasal Cannula(HFNC)

ACTIVE COMPARATOR

HFNC produce a better physiological outcomes after 1-hour intervention

Device: hCPAP versus HFNC

Interventions

hCPAP versus HFNCDEVICE

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

Helmet Continuous Positive Airway Pressure(hCPAP)High Flow Nasal Cannula(HFNC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 34632507DERIVED

MeSH Terms

Conditions

Pulmonary EdemaRespiratory InsufficiencyHyperemia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • ADI OSMAN

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
EMERGENCY MEDICINE CONSULTANT

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 2, 2019

Study Start

January 1, 2018

Primary Completion

August 31, 2018

Study Completion

September 30, 2018

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)