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

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Fisher & Paykel Healthcare

Status

Enrolling

Conditions

COPD

Treatments

Device: Closed loop oxygen control
Device: Manual titration

Study type

Interventional

Funder types

Industry

Identifiers

NCT07222410
CIA-334

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Airvo 3 (with OptiO2) OptiO2 mode on
Experimental group
Treatment:
Device: Closed loop oxygen control
Airvo 3 (with OptiO2) OptiO2 mode off
Active Comparator group
Treatment:
Device: Manual titration

Trial contacts and locations

1

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Central trial contact

Jenny Han

Data sourced from clinicaltrials.gov

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