Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure

Acute Hypoxemic Respiratory Failure Clinical Trial

Official title:

Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01166256
• Other study ID #: HFNCinAHRF
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 19, 2010
• Last updated: July 20, 2010
• Start date: July 2010

Study information

• Verified date: July 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However, invasive mechanical ventilation is associated with a variety of complications. Non-invasive ventilation has been presented as an alternative treatment but controversy remains. The investigators hypothesize that high-flow nasal cannula system is effective enough to prevent intubation in acute hypoxemic respiratory failure and not inferior to non-invasive ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18

• patients with acute hypoxemic respiratory failure

Exclusion Criteria:

• age < 18 years

• hypercapnia (arterial carbon dioxide tension (PaCO2) >45mmHg) at admission

• need for emergency intubation, including cardiopulmonary resuscitation

• recent esophageal, facial or cranial trauma or surgery

• severely decreased consciousness (Glasgow coma score <11)

• cardiogenic shock or severe hemodynamic instability

• systolic blood pressure <90 mmHg associated with decreased urinary output(<20 mL.h-1) despite fluid repletion and use of vasoactive agents

• lack of co-operation

• altered mental status with decreased consciousness and/or evidence of inability to understand or lack of willingness to co-operate with the procedures

• tracheotomy or other upper airway disorders

• severe ventricular arrhythmia or active myocardial ischemia

• active upper gastrointestinal bleeding

• inability to clear respiratory secretions

• more than one severe organ dysfunction in addition to respiratory failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Non-invasive ventilation
Noninvasive ventilation: The inspiratory(IPAP) and expiratory positive airways pressure (EPAP), and the levels of FiO2 is set achieve SpO2 >92% or PaO2 >65 mmHg.
• High flow nasal cannula system
High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 >92% or PaO2 >65 mmHg.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of treatment in two groups	Successful treatment is to avoid intubation and achieve PaO2 >75 mmHg without respiratory distress for 24 hours while spontaneously breathing oxygen provided by a Venturi device at FiO2 0.50.	up to 28 days	No
Secondary	compliance of treatment	Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance	up to 28 days	No
Secondary	adverse event		up to 28 days	Yes
Secondary	hospital length of stay		up to 90 days	No
Secondary	Hospital mortality		up to 90 days	Yes