Recruiting

FreeO2

Sponsor:

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

Code:

NCT01393015

Conditions

COPD Exacerbation

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Automated settings on the oxygen delivery device

Manual settings with FreeO2 system in collection mode

Study Details

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.

Conditions

COPD Exacerbation

Study ID

NCT01393015

Start date

Jul, 2011

Status verified date

May, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

experimental: FreeO2 system

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.

active comparator: Rotameter (flowmeter)

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

Interventions

Automated settings on the oxygen delivery device

FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.

Manual settings with FreeO2 system in collection mode

Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.

Primary outcome measure

  • Possibility to use a new closed-loop system for oxygen delivery in common practice [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Pierre-Alexandre Bouchard, inh

1 418 656-8711pierre-alexandre.bouchard.1@ulaval.ca

Maude Roberge

maude.roberge.1@ulaval.ca

Locations

Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec

Recruiting

Quebec city, Quebec, Canada, G1V 4G5

Contacts

Pierre-Alexandre Bouchard, inh

1-418-656-8711pierre-alexandre.bouchard.1@ulaval.ca

Maude Roberge

maude.roberge.1@ulaval.ca

More Information

Sponsor

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

Last update posted

Jul 13, 2011

Last verified

May, 2011

Keywords

  • automatic
  • automation
  • oxygen
  • weaning
  • COPD
  • exacerbation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec on 2011-07-13.