← Back to Search

Device

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

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
Select...
I have recently been experiencing worsening shortness of breath.
Select...
I am over 40 and have a history of heavy smoking.
Select...
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:
Select...
I have chosen not to participate in this trial.
Select...
My condition is in the final stages, either due to cancer or severe breathing problems.
Select...
My COPD worsening is closely linked to a lung clot, heart-related lung swelling, lung collapse, or too much sedative.
Select...
I need help breathing with a machine.
Select...
I have not experienced delirium.

Timeline

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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospital length of stay
Secondary study objectives
ICU transfer
Non invasive or invasive mechanic ventilation rate use
Oxygen administration duration
Other study objectives
Arterial or Capillary blood gaz evolution
Hospital Readmission rate after hospital discharge

Trial Design

2Treatment groups
Experimental Treatment
Group I: Manual Oxygen titrationExperimental Treatment1 Intervention
In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff
Group II: Automated Oxygen titrationExperimental Treatment1 Intervention
In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FreeO2
2017
N/A
~80

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor
423 Previous Clinical Trials
172,926 Total Patients Enrolled
2 Trials studying Oxygen Toxicity
256 Patients Enrolled for Oxygen Toxicity

Media Library

FreeO2 (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03835741 — N/A
Oxygen Toxicity Research Study Groups: Automated Oxygen titration, Manual Oxygen titration
Oxygen Toxicity Clinical Trial 2023: FreeO2 Highlights & Side Effects. Trial Name: NCT03835741 — N/A
FreeO2 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03835741 — N/A
~17 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top