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

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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
Sponsor:
Information provided by:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Brief 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.


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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2. [ Time Frame: 6 months ]
  2. Percentage of time with desaturation during the oxygentherapy [ Time Frame: 6 months ]
  3. Percentage of time with hyperoxia during the oxygentherapy [ Time Frame: 6 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393015


Contacts
Contact: Pierre-Alexandre Bouchard, inh 1 418 656-8711 ext 2712 pierre-alexandre.bouchard.1@ulaval.ca
Contact: Maude Roberge maude.roberge.1@ulaval.ca

Locations
Canada, Quebec
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    pierre-alexandre.bouchard.1@ulaval.ca   
Contact: Maude Roberge       maude.roberge.1@ulaval.ca   
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators
Principal Investigator: François Lellouche, Md Institut universitaire de cardiologie et de pneumologie de Québec

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: François Lellouche, MD, CRIUCPQ
ClinicalTrials.gov Identifier: NCT01393015     History of Changes
Other Study ID Numbers: FreeO2-COPD-5ePC
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: May 2011

Keywords provided by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
automatic
automation
oxygen
weaning
COPD
exacerbation

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases