COPD Exacerbation, Hyperoxia, Hypoxemia, Hypoxic Respiratory Failure, Oxygen Toxicity
Conditions
Brief summary
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
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.
Interventions
DEVICEFreeO2
an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
OTHERmanual titration
a manual adjustment of oxygen during patient hospitalisation by hospital staff
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | From hospital admission until hospital discharge (around one week expected) | Duration of the hospital length of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU transfer | During hospital stay : from hospital admission until hospital discharge (around one week expected) | The rate of ICU admission during hospital stay |
| Oxygen administration duration | During hospital stay : from hospital admission until hospital discharge (around one week expected) | The number of days patient receive oxygen supplementation |
| Non invasive or invasive mechanic ventilation rate use | During hospital stay: from hospital admission until hospital discharge (around one week expected) | The rate of NIV use during length of stay in hospital |
Other
| Measure | Time frame | Description |
|---|---|---|
| Arterial or Capillary blood gaz evolution | During hospital stay - From hospital admission until hospital discharge (around one week expected) | Evaluation of the rate of respiratory acidosis (pH\<7.35 and PaCO2\>45mmHg) |
| Hospital Readmission rate after hospital discharge | Until day 90 after study inclusion | Rate of hospital readmission after initial hospital discharge |
Countries
Canada
Outcome results
None listed