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

COPD Exacerbation Clinical Trial

Official title:

Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With Exacerbations of Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01393015
• Other study ID #: FreeO2-COPD-5ePC
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2011
• Last updated: July 12, 2011
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Contact: Pierre-Alexandre Bouchard, inh
• Phone: 1 418 656-8711
• Email: pierre-alexandre.bouchard.1[@]ulaval.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec	Quebec city	Quebec

Sponsors (1)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Possibility to use a new closed-loop system for oxygen delivery in common practice	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.	6 months	No
Secondary	Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.		6 months	No
Secondary	Percentage of time with desaturation during the oxygentherapy		6 months	No
Secondary	Percentage of time with hyperoxia during the oxygentherapy		6 months	No