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Recruiting NCT07222410

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

No phase Interventional COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Closed loop oxygen control, Manual titration.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Closed loop oxygen control
    Nasal high flow with closed loop oxygen control
  • Device Manual titration
    Nasal high flow with manual titration

Primary outcome measures

  • Percentage of time with SpO2 in target range over period of observation [Time frame: 24 hours]
  • Percentage of time with SpO2 out of target range over period of observation [Time frame: 24 hours]
Secondary outcome measures (3)
  • Count of number of adjustments in FiO2 by clinical staff over observation period [Time frame: 24 hours]
  • Percentage of time with SpO2 above target range over period of observation [Time frame: 24 hours]
  • Percentage of time with SpO2 below target range over period of observation [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • The University of Alabama at Birmingham — Birmingham
  • Central Iowa Hospital Corp - UnityPoint Health — Des Moines
  • Icahn School of Medicine at Mount Sinai — New York
  • Temple University Hospital — Philadelphia

Identifiers

NCT: NCT07222410 · CIA-334

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗