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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hospital stay: from hospital admission until hospital discharge (around one week expected)
Awards & highlights
FreeO2 HypHop Trial 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.Check my eligibility
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.See study design
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.
FreeO2 HypHop Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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%.
FreeO2 HypHop Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during hospital stay : from hospital admission until hospital discharge (around one week expected)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospital stay : from hospital admission until hospital discharge (around one week expected)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital length of stay
Secondary outcome measures
ICU transfer
Non invasive or invasive mechanic ventilation rate use
Oxygen administration duration
Other outcome measures
Arterial or Capillary blood gaz evolution
Hospital Readmission rate after hospital discharge
FreeO2 HypHop 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
2016
N/A
~30
Find a Location
Who is running the clinical trial?
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,170 Total Patients Enrolled
2 Trials studying Oxygen Toxicity
256 Patients Enrolled for Oxygen Toxicity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chosen not to participate in this trial.The patient is not able or willing to cooperate with the study requirements.You have a brain condition with a score higher than 2.I have recently been experiencing worsening shortness of breath.You are currently dependent on life support and are unable to be taken off it for the duration of the study.I am over 40 and have a history of heavy smoking.The FreeO2 device is not available when you are scheduled for the study.I have more mucus, changes in mucus color, or increased difficulty breathing.My condition is in the final stages, either due to cancer or severe breathing problems.My COPD worsening is closely linked to a lung clot, heart-related lung swelling, lung collapse, or too much sedative.I need help breathing with a machine.I have not experienced delirium.There is no signal for measuring the amount of oxygen in your blood.I need less than 8 liters per minute of oxygen to keep my oxygen levels above 92%.
Research Study Groups:
This trial has the following groups:- Group 1: Automated Oxygen titration
- Group 2: Manual Oxygen titration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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