Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 13, 2011
May 1, 2011
5 months
July 11, 2011
July 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
FreeO2 system
EXPERIMENTALFreeO2 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.
Rotameter (flowmeter)
ACTIVE COMPARATORA rotameter is a device that measures the flow rate of liquid or gas in a closed tube.
Interventions
FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.
Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.
Eligibility Criteria
You may qualify if:
- Patient hospitalized for COPD exacerbation
- 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%
You may not qualify if:
- Imminent indications for intubation
- FreeO2 system is unavailable at the moment of randomization
- Patient participates to another clinical trial without possibility of co-enrollment
- Patient with diagnosis of sleep apnea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
Related Publications (1)
Poder TG, Kouakou CRC, Bouchard PA, Tremblay V, Blais S, Maltais F, Lellouche F. Cost-effectiveness of FreeO2 in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec. BMJ Open. 2018 Jan 23;8(1):e018835. doi: 10.1136/bmjopen-2017-018835.
PMID: 29362258DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Lellouche, Md
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 13, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 13, 2011
Record last verified: 2011-05