Closed Loop Oxygen Control in Hospitalized COPD Patients
Closed loop oxygen control
+ Manual titration
Hypoxia+8
+ Chronic Disease
+ Lung Diseases
Treatment Study
Summary
Study start date: November 1, 2025
Actual date on which the first participant was enrolled.This clinical trial explores a new way to help people with Chronic Obstructive Pulmonary Disease (COPD) who are in the hospital because they have difficulty breathing and low oxygen levels, known as hypoxemia. The study is testing a device called Airvo 3, which has a special OptiO2 mode that automatically adjusts the oxygen levels for the patient. The goal is to see if this device can keep oxygen levels more stable compared to the usual method where healthcare professionals manually adjust the oxygen. This is important because more stable oxygen levels could lead to better outcomes and more comfort for patients with COPD. In this study, participants with COPD will use the Airvo 3 device while staying in the hospital. The device is designed to deliver oxygen through the nose, known as nasal high flow. Researchers will compare how well the device maintains the desired oxygen levels against the standard practice of manually adjusting oxygen. By measuring how consistently the device keeps the patient’s oxygen at the right level, the study aims to determine if this method is more effective. There are no specific risks or benefits mentioned, but a more stable oxygen level could potentially improve the patient's overall condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 22 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives