Print

Purpose

The trial aims to evaluate whether the Airvo 3 device in OptiO2 mode can maintain patients' SpO2 levels within the target range better than manual oxygen titration in hospitalized COPD patients with hypoxemia/respiratory distress.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has cognitive ability to provide informed consent - Aged 22 years or older - Hospitalized with hypoxemia/respiratory distress - Diagnosis of COPD - Candidate for/currently prescribed nasal high flow (flow rate of at least 25 L/min) with supplemental oxygen, as assessed by the investigator - Expected duration of oxygen and nasal high flow therapy >24 hours (not necessarily continuous)

Exclusion Criteria

  • Receiving Non Invasive Ventilation (NIV) or indicated for NIV as per European Respiratory Society /American Thoracic Society guidelines - Hemodynamic instability (systolic blood pressure <90mmHg or requirement for vasopressor or inotropic support) - Patient receiving end of life care - Nasal or facial conditions precluding use of nasal high flow - Pregnancy or breastfeeding - Cognitive impairment or impaired consciousness precluding informed consent - Unsuitable for adhesive finger pulse oximetry, as assessed by the investigator - Any other condition which, at the investigator's discretion, is believed to present a safety risk to the patient if included - The presence of any active comorbidities that affect the patient's condition importantly in the next 30 days, as assessed by the investigator - Has already participated in this clinical trial

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Airvo 3 (with OptiO2) OptiO2 mode on
  • Device: Closed loop oxygen control
    Nasal high flow with closed loop oxygen control
Active Comparator
Airvo 3 (with OptiO2) OptiO2 mode off
  • Device: Manual titration
    Nasal high flow with manual titration

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Raymond C Wade
205-934-2490
rcwade@uab.edu

More Details

Status
Recruiting
Sponsor
Fisher and Paykel Healthcare

Study Contact

Jenny Han
64 9 574 0123
optio2trial@fphcare.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.