Clinical trial NCT01393015: Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation
Official title: Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With Exacerbations of Chronic Obstructive Pulmonary Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Keywords: automatic
automation
oxygen
weaning
COPD
exacerbation
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Possibility to use a new closed-loop system for oxygen delivery in common practice
timeFrame: 6 months
Secondary outcomes:
measure: Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.
timeFrame: 6 months
measure: Percentage of time with desaturation during the oxygentherapy
timeFrame: 6 months
measure: Percentage of time with hyperoxia during the oxygentherapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Quebec city
country: Canada
facility: Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: François Lellouche, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.