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

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Status: Unknown

Conditions: COPD Exacerbation

Treatments: Device: Automated settings on the oxygen delivery device; Device: Manual settings with FreeO2 system in collection mode

Study type: Interventional

Funder types: Other

Identifiers

NCT01393015

FreeO2-COPD-5ePC

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

FreeO2 system

Experimental group

Description:

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.

Treatment:

Device: Automated settings on the oxygen delivery device

Rotameter (flowmeter)

Active Comparator group

Description:

A rotameter is a device that measures the flow rate of liquid or gas in a closed tube.

Treatment:

Device: Manual settings with FreeO2 system in collection mode