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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier:
NCT01393015
First received: July 11, 2011
Last updated: July 12, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
COPD Exacerbation
 Device: Automated settings on the oxygen delivery device
Device: Manual settings with FreeO2 system in collection mode

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:

Primary Outcome Measures:
  • Possibility to use a new closed-loop system for oxygen delivery in common practice [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of time with desaturation during the oxygentherapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of time with hyperoxia during the oxygentherapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: François Lellouche, MD, CRIUCPQ
ClinicalTrials.gov Identifier: NCT01393015     History of Changes
Other Study ID Numbers: FreeO2-COPD-5ePC
Study First Received: July 11, 2011
Last Updated: July 12, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 19, 2013