Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

Study Overview
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Brief Summary
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The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.

Detailed Description
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The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration. Patients with severe acute exacerbation of COPD requiring hospitalization will be included in this randomized controlled study and will be managed with either manual oxygen titration or automated oxygen titration (FreeO2 arm). The impact on the hospital length of stay will be evaluated.

Official Title
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Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

Conditions
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Oxygen Toxicity, COPD Exacerbation, Hyperoxia, Hypoxemia, Hypoxic Respiratory Failure

Intervention / Treatment
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* Device: FreeO2
* Other: manual titration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD or suspected COPD ( Age>40, active or smoking history > 10pack/years), - Acute exacerbation (increasing dyspnea recently) One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea, Moderate oxygen therapy: Oxygen flow < 8 lpm (or FiO2 < 0.60) to maintain a SpO2 >or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 > or = 92%) Exclusion Criteria: Patient refusal COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose No SpO2 signal Encephalopathy score > 2 Delirium Other respiratory support needed (intubation or NIV) Patient on withdrawal life support Advance neoplasia (palliative stage) or terminal respiratory distress Unavailability of FreeO2 device at the randomisation Non optimal patient collaboration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated Oxygen titration<br>In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device | Device: FreeO2<br>* an automated adjustment of oxygen during patient hospitalisation by FreeO2 device<br>|
| Other: Manual Oxygen titration<br>In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff | Other: manual titration<br>* a manual adjustment of oxygen during patient hospitalisation by hospital staff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Duration of the hospital length of stay | From hospital admission until hospital discharge (around one week expected) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU transfer | The rate of ICU admission during hospital stay | During hospital stay : from hospital admission until hospital discharge (around one week expected) | 
| Oxygen administration duration | The number of days patient receive oxygen supplementation | During hospital stay : from hospital admission until hospital discharge (around one week expected) | 
| Non invasive or invasive mechanic ventilation rate use | The rate of NIV use during length of stay in hospital | During hospital stay: from hospital admission until hospital discharge (around one week expected) |