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

May 3, 2026 updated by: Fisher and Paykel Healthcare

Closed Loop Oxygen Control in COPD Patients Treated With Nasal High Flow in the Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Central Iowa Hospital Corp - UnityPoint Health
        • Contact:
    • New York
      • New York, New York, United States, 10029
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time with SpO2 in target range over period of observation
Time Frame: 24 hours
24 hours
Percentage of time with SpO2 out of target range over period of observation
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Count of number of adjustments in FiO2 by clinical staff over observation period
Time Frame: 24 hours
24 hours
Percentage of time with SpO2 above target range over period of observation
Time Frame: 24 hours
24 hours
Percentage of time with SpO2 below target range over period of observation
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

October 23, 2025

First Submitted That Met QC Criteria

October 27, 2025

First Posted (Actual)

October 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sensitivity of data, data will be used for FDA submission

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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