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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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COPD Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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FreeO2 system

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 Type EXPERIMENTAL

Automated settings on the oxygen delivery device

Intervention Type DEVICE

FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.

Rotameter (flowmeter)

A rotameter is a device that measures the flow rate of liquid or gas in a closed tube.

Group Type ACTIVE_COMPARATOR

Manual settings with FreeO2 system in collection mode

Intervention Type DEVICE

Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.

Interventions

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Automated settings on the oxygen delivery device

FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.

Intervention Type DEVICE

Manual settings with FreeO2 system in collection mode

Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No