Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.

Official Title
-----------------
Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Conditions
-----------------
Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified

Intervention / Treatment
-----------------
* Device: Non-invasive mechanical ventilation - Normoxia
* Device: Non-invasive mechanical ventilation - Controlled hypoxemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Acute hypercapnic COPD exacerbation Respiratory acidosis Intensive care unit admission Non-Invasive mechanical ventilation for less than 24 hours Patients or proxy consent Patients affiliated with the General Social Security Health System Exclusion Criteria: Pregnancy Sickle cells disease Acute coronary syndrome Restrictive respiratory disease Stage 4 or 5 chronic kidney disease COPD exacerbation following a first episode of conventional mechanical ventilation Contraindications to non-invasive ventilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br> | Device: Non-invasive mechanical ventilation - Normoxia<br>* Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)<br>|
| Other: control<br> | Device: Non-invasive mechanical ventilation - Controlled hypoxemia<br>* Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary output (ml) | First 24 hours of non-invasive mechanical ventilation | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CO2 levels | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration) | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72 hours | 
| Serum creatinine | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| Renal resistive index | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| Pulmonary arterial pressure | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| Semiquantitative assessment of dyspnea (visual likert scale) | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| Semiquantitative assessment of comfort (visual likert scale) | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| Fluid balance | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| SOFA (Sequential Organ Failure Assessment) score | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours | 
| Mortality | First 24 hours of non-invasive mechanical ventilation | up to day 28 | 
| Number of patients requiring mechanical ventilation | Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge | up to day 28 | 
| days alive without mechanical ventilation | Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge | up to day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Noninvasive Ventilation, Pulmonary Disease, Chronic Obstructive, Renal Doppler, Oxygen, Hypercapnia