NCT07222410

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Nov 2027

First Submitted

Initial submission to the registry

October 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 5, 2026

Status Verified

October 1, 2025

Enrollment Period

1.8 years

First QC Date

October 23, 2025

Last Update Submit

May 3, 2026

Conditions

COPD

Keywords

COPDclosed loop oxygen controlhypoxemianasal high flow

Outcome Measures

Primary Outcomes (2)

  • Percentage of time with SpO2 in target range over period of observation

    24 hours

  • Percentage of time with SpO2 out of target range over period of observation

    24 hours

Secondary Outcomes (3)

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

    24 hours

  • Percentage of time with SpO2 above target range over period of observation

    24 hours

  • Percentage of time with SpO2 below target range over period of observation

    24 hours

Study Arms (2)

Airvo 3 (with OptiO2) OptiO2 mode on

EXPERIMENTAL
Device: Closed loop oxygen control

Airvo 3 (with OptiO2) OptiO2 mode off

ACTIVE COMPARATOR
Device: Manual titration

Interventions

Closed loop oxygen controlDEVICE

Nasal high flow with closed loop oxygen control

Airvo 3 (with OptiO2) OptiO2 mode on
Manual titrationDEVICE

Nasal high flow with manual titration

Airvo 3 (with OptiO2) OptiO2 mode off

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Central Iowa Hospital Corp - UnityPoint Health

Des Moines, Iowa, 50309, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypoxia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Central Study Contacts

Jenny Han

CONTACT

64 9 574 0123optio2trial@fphcare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2025

First Posted

October 29, 2025

Study Start

January 7, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

May 5, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Sensitivity of data, data will be used for FDA submission

Locations

US(3)