Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital

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

  • COPD

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