Automated Oxygen Adjustment for COPD Exacerbations (FreeO2 HypHop Trial)

N/A

Recruiting

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute exacerbation (increasing dyspnea recently)

COPD or suspected COPD (Age > 40, active or smoking history > 10 pack/years)

Must not have

Patient refusal

Advance neoplasia (palliative stage) or terminal respiratory distress

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until day 90 after study inclusion

Awards & highlights

No Placebo-Only Group

Summary

This trial studies automated oxygen delivery to reduce hospital stay for COPD exacerbations, compared to manual oxygen titration.

Who is the study for?

This trial is for adults over 40 with COPD or suspected COPD, who have a history of smoking and are experiencing an acute exacerbation. They should need moderate oxygen therapy to maintain certain blood oxygen levels but not require advanced respiratory support like intubation. Patients with conditions such as pulmonary embolism, cardiac issues, pneumothorax, or severe encephalopathy cannot participate.

What is being tested?

The study compares two ways of giving oxygen to patients: one uses the FreeO2 device that automatically adjusts oxygen levels, while the other method involves manual adjustment by healthcare staff. The goal is to see if the FreeO2 can shorten hospital stays for those having a severe flare-up of their COPD.

What are the potential side effects?

Potential side effects may include discomfort from wearing the device and possible skin irritation where it's attached. There could also be risks related to improper oxygen levels like too much (oxygen toxicity) or too little (hypoxia), although the aim of FreeO2 is to minimize these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recently been experiencing worsening shortness of breath.

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I am over 40 and have a history of heavy smoking.

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I need less than 8 liters per minute of oxygen to keep my oxygen levels above 92%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chosen not to participate in this trial.

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My condition is in the final stages, either due to cancer or severe breathing problems.

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My COPD worsening is closely linked to a lung clot, heart-related lung swelling, lung collapse, or too much sedative.

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I need help breathing with a machine.

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I have not experienced delirium.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from hospital admission until hospital discharge (around one week expected)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from hospital admission until hospital discharge (around one week expected)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from hospital admission until hospital discharge (around one week expected) for reporting.