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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FreeO2 system | Experimental | 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. |
|
| Rotameter (flowmeter) | Active Comparator | A rotameter is a device that measures the flow rate of liquid or gas in a closed tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated settings on the oxygen delivery device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time 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 oxygentherapy | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-Alexandre Bouchard, inh | Contact | 1 418 656-8711 | 2712 | pierre-alexandre.bouchard.1@ulaval.ca |
| Maude Roberge | Contact | maude.roberge.1@ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| François Lellouche, Md | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'institut universitaire de cardiologie et de pneumologie de Québec | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29362258 | Derived | Poder TG, Kouakou CRC, Bouchard PA, Tremblay V, Blais S, Maltais F, Lellouche F. Cost-effectiveness of FreeO2 in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec. BMJ Open. 2018 Jan 23;8(1):e018835. doi: 10.1136/bmjopen-2017-018835. |
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| Manual settings with FreeO2 system in collection mode | Device | Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization. |
|
| Percentage of time with hyperoxia during the oxygentherapy | 6 months |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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