Clinical trial NCT02563314: Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease
Official title: Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
Keywords: Noninvasive Ventilation
Pulmonary Disease
Chronic Obstructive
Renal Doppler
Oxygen
Hypercapnia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: urinary output (ml)
timeFrame: 24 hours
Secondary outcomes:
measure: Changes in CO2 levels
timeFrame: 24 hours, 48 hours, 72hours
measure: respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration)
timeFrame: 24 hours, 48 hours, 72 hours
measure: Serum creatinine
timeFrame: 24 hours, 48 hours, 72hours
measure: Renal resistive index
timeFrame: 24 hours, 48 hours, 72hours
measure: Pulmonary arterial pressure
timeFrame: 24 hours, 48 hours, 72hours
measure: Semiquantitative assessment of dyspnea (visual likert scale)
timeFrame: 24 hours, 48 hours, 72hours
measure: Semiquantitative assessment of comfort (visual likert scale)
timeFrame: 24 hours, 48 hours, 72hours
measure: Fluid balance
timeFrame: 24 hours, 48 hours, 72hours
measure: SOFA (Sequential Organ Failure Assessment) score
timeFrame: 24 hours, 48 hours, 72hours
measure: Mortality
timeFrame: up to day 28
measure: Number of patients requiring mechanical ventilation
timeFrame: up to day 28
measure: days alive without mechanical ventilation
timeFrame: up to day 28
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU de CLERMONT-FERRAND
city: Grenoble
country: France
facility: CHu de GRENOBLE
city: Paris
country: France
facility: CHU de la Pitié-Salpêtrière
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Michael DARMON, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: