NCT04014088

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

July 4, 2019

Last Update Submit

March 12, 2025

Conditions

Acute Cardiogenic Pulmonary Edema

Keywords

helmet CPAPfacemask CPAPpulmonary edemanon invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Respiratory Rate

    Respiratory rate change post intervention

    1 hour

Secondary Outcomes (6)

  • Heart Rate

    1 hour

  • Partial Pressure of Arterial Oxygen Level

    1 hour

  • Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen

    1 hour

  • Dyspnea Scale

    1 hour

  • Partial Pressure of Arterial Carbon Dioxide level

    1 hour

  • +1 more secondary outcomes

Study Arms (2)

helmet CPAP

ACTIVE COMPARATOR

helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema

Device: hCPAP vs fCPAP

facemask CPAP

ACTIVE COMPARATOR

facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema

Device: hCPAP vs fCPAP

Interventions

hCPAP vs fCPAPDEVICE

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

facemask CPAPhelmet CPAP

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
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

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Adi Osman

    Emergency Department, Hospital Raja Permaisuri Bainun

    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

July 4, 2019

First Posted

July 10, 2019

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

January 10, 2018

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share