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

COPD Exacerbation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

COPD Exacerbation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Automated settings on the oxygen delivery deviceFreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.

Device:Manual settings with FreeO2 system in collection modeOxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

FreeO2 systemFreeO2 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)A rotameter is a device that measures the flow rate of liquid or gas in a closed tube.

Study Status

Unknown status

Start Date: July 2011

Completed Date: December 2011

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Possibility to use a new closed-loop system for oxygen delivery in common practice

Secondary Outcome: Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.

Study sponsors, principal investigator, and references

Principal Investigator: Fran├žois Lellouche, Md

Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01393015

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