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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01393015
Enrollment
50
Registered
2011-07-13
Start date
2011-07-31
Completion date
2011-12-31
Last updated
2011-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Keywords

automatic, automation, oxygen, weaning, COPD, exacerbation

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.

Interventions

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

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Possibility to use a new closed-loop system for oxygen delivery in common practice6 monthsWe 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

MeasureTime frame
Time of oxygen weaning between common oxygen delivery and closed-loop automatic titration of oxygen flow based on SpO2.6 months
Percentage of time with desaturation during the oxygentherapy6 months
Percentage of time with hyperoxia during the oxygentherapy6 months

Countries

Canada

Contacts

Primary ContactPierre-Alexandre Bouchard, inh
pierre-alexandre.bouchard.1@ulaval.ca1 418 656-8711
Backup ContactMaude Roberge
maude.roberge.1@ulaval.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026