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Clinical Trials/NCT04005092
NCT04005092
Completed
Not Applicable

Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial

Hospital Raja Permaisuri Bainun1 site in 1 country188 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiogenic Pulmonary Edema
Sponsor
Hospital Raja Permaisuri Bainun
Enrollment
188
Locations
1
Primary Endpoint
Respiratory Rate
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
September 30, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Adi Bin Osman

EMERGENCY MEDICINE CONSULTANT

Hospital Raja Permaisuri Bainun

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
  • Upper airway obstruction

Outcomes

Primary Outcomes

Respiratory Rate

Time Frame: 1 hour

Respiratory rate reduction post intervention

Secondary Outcomes

  • Heart Rate(1 hour)
  • Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score(1 hour)
  • Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen(1 hour)
  • Dyspnoea Scale(1 hour)
  • Partial Pressure Of Arterial Oxygen Level(1 hour)
  • Rate Of Intubation(1 hour)
  • 28-Days Mortality In Acute Cardiogenic Pulmonary Edema(28 days)

Study Sites (1)

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