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FreeO2 system for Chronic Obstructive Pulmonary Disease

N/A
Waitlist Available
Led By François Lellouche, Md
Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen and to enable a remote medical monitoring with a homogeneous patient population hospitalize for Chronic obstructive pulmonary disease (COPD)exacerbation. Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel and to improve the support with centralized monitoring in the FreeO2 group.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Possibility to use a new closed-loop system for oxygen delivery in common practice
Secondary outcome measures
Percentage of time with desaturation during the oxygentherapy
Percentage of time with hyperoxia during the oxygentherapy
Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FreeO2 systemExperimental Treatment1 Intervention
FreeO2 is a new system that automatically adjusts the oxygen flow delivered to patients in closed-loop based on the SpO2 signal. This system is intended to maintain SpO2 in a predefined target and to adapt oxygen flow to patient's needs.
Group II: Rotameter (flowmeter)Active Control1 Intervention
A rotameter is a device that measures the flow rate of liquid or gas in a closed tube.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Automated settings on the oxygen delivery device
2012
N/A
~20

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor
36 Previous Clinical Trials
9,692 Total Patients Enrolled
François Lellouche, MdPrincipal InvestigatorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation
2011. "Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01393015.
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