Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation

Study Overview
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Brief Summary
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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.

Official Title
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Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With Exacerbations of Chronic Obstructive Pulmonary Disease.

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Device: Automated settings on the oxygen delivery device
* Device: Manual settings with FreeO2 system in collection mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient hospitalized for COPD exacerbation 40 Years and older Former or current smoker greater than or equal to 10 pack-years Suspicion or diagnosis of COPD at the hospitalisation Acute dyspnea or acute aggravation of dyspnea Respiratory rate greater than or equal to 20 breaths/min Patient needs an oxygen therapy by nasal cannula with oxygen delivered between 0.5 to 8L/min to hold SpO2 greater than or equal to 92% Exclusion Criteria: Imminent indications for intubation FreeO2 system is unavailable at the moment of randomization Patient in isolation (barrier nursing) to the inclusion Patient participates to another clinical trial without possibility of co-enrollment Patient with diagnosis of sleep apnea

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FreeO2 system<br>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. | Device: Automated settings on the oxygen delivery device<br>* FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.<br>|
| Active Comparator: Rotameter (flowmeter)<br>A rotameter is a device that measures the flow rate of liquid or gas in a closed tube. | Device: Manual settings with FreeO2 system in collection mode<br>* Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possibility to use a new closed-loop system for oxygen delivery in common practice | We will see if nurses and medical personnel are agree to work with FreeO2 system. We want to know if the new system of automated adjustment of oxygen flow is useful in common practice. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2. |  | 6 months | 
| Percentage of time with desaturation during the oxygentherapy |  | 6 months | 
| Percentage of time with hyperoxia during the oxygentherapy |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automatic, automation, oxygen, weaning, COPD, exacerbation