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

NCT ID: NCT07222410

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-07

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Airvo 3 (with OptiO2) OptiO2 mode on

Group Type EXPERIMENTAL

Closed loop oxygen control

Intervention Type DEVICE

Nasal high flow with closed loop oxygen control

Airvo 3 (with OptiO2) OptiO2 mode off

Group Type ACTIVE_COMPARATOR

Manual titration

Intervention Type DEVICE

Nasal high flow with manual titration

Interventions

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Closed loop oxygen control

Nasal high flow with closed loop oxygen control

Intervention Type DEVICE

Manual titration

Nasal high flow with manual titration

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jenny Han

Role: CONTACT

64 9 574 0123

Facility Contacts

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Kathryn Dubowski

Role: primary

212 420 2377

Other Identifiers

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CIA-334

Identifier Type: -

Identifier Source: org_study_id

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