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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 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%.

FreeO2 HypHop Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospital stay : from hospital admission until hospital discharge (around one week expected)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospital stay : from hospital admission until hospital discharge (around one week expected) for reporting.

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~10 spots leftby Dec 2024