Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation
|ClinicalTrials.gov Identifier: NCT01393015|
Recruitment Status : Unknown
Verified May 2011 by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec.
Recruitment status was: Recruiting
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Device: Automated settings on the oxygen delivery device Device: Manual settings with FreeO2 system in collection mode||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With Exacerbations of Chronic Obstructive Pulmonary Disease.|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
Experimental: 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.
Device: 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.
Active Comparator: Rotameter (flowmeter)
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
Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.
- Possibility to use a new closed-loop system for oxygen delivery in common practice [ Time Frame: 6 months ]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.
- Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2. [ Time Frame: 6 months ]
- Percentage of time with desaturation during the oxygentherapy [ Time Frame: 6 months ]
- Percentage of time with hyperoxia during the oxygentherapy [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393015
|Contact: Pierre-Alexandre Bouchard, inh||1 418 656-8711 ext firstname.lastname@example.org|
|Contact: Maude Robergeemail@example.com|
|Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec||Recruiting|
|Quebec city, Quebec, Canada, G1V 4G5|
|Contact: Pierre-Alexandre Bouchard, inh 1-418-656-8711 ext 2712 firstname.lastname@example.org|
|Contact: Maude Roberge email@example.com|
|Principal Investigator:||François Lellouche, Md||Institut universitaire de cardiologie et de pneumologie de Québec|