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

ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorFisher and Paykel Healthcare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has cognitive ability to provide informed consent

Aged 22 years or older

Hospitalized with hypoxemia/respiratory distress

Diagnosis of COPD

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Closed loop oxygen control

    Device

    Nasal high flow with closed loop oxygen control

  • Manual titration

    Device

    Nasal high flow with manual titration

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Airvo 3 (with OptiO2) OptiO2 mode onExperimental treatment 1 intervention
Group B: Airvo 3 (with OptiO2) OptiO2 mode offActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fisher and Paykel Healthcare

Lead sponsor

Source ClinicalTrials.gov
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