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

Not Applicable

• Conditions: COPD Exacerbation

• Registration Number: NCT01393015
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-05
• Study Start: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-12
• Last Update Submitted: 2011-07-12
• Study First Posted: 2011-07-13
• Last Update Posted: 2011-07-13
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Possibility to use a new closed-loop system for oxygen delivery in common practice	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

Name	Time	Method
Percentage of time with desaturation during the oxygentherapy	6 months
Percentage of time with hyperoxia during the oxygentherapy	6 months
Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.	6 months

Trial Locations

Locations (1)

Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Quebec city, Quebec, Canada