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NCT Number: NCT07222410

Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (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.

Recruiting

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed loop oxygen control

Device

Nasal high flow with closed loop oxygen control

Manual titration

Device

Nasal high flow with manual titration

Primary outcomes

  1. Percentage of time with SpO2 in target range over period of observation

    Time frame: 24 hours

  2. Percentage of time with SpO2 out of target range over period of observation

    Time frame: 24 hours

Secondary outcomes

  1. Count of number of adjustments in FiO2 by clinical staff over observation period

    Time frame: 24 hours

  2. Percentage of time with SpO2 above target range over period of observation

    Time frame: 24 hours

  3. Percentage of time with SpO2 below target range over period of observation

    Time frame: 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Han

CONTACT

[email protected]

64 9 574 0123

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 29, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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