A Phase 3 interventional study of Modulation of Inspired Fraction of Oxygen (FiO2) in Acute Respiratory Distress Syndrome and Intensive Care, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by Centre Hospitalier Universitaire de Besancon · Phase 3, Interventional, and Treatment
No clear recommendation exists for the level of oxygenation of intensive care patients. In Acute Respiratory Distress Syndrome (ARDS), pulsed oxymetry (SpO2) have to be kept between 88 and 95 percent and oxygen alveolar pressure between 55 and 80 mmHg (PaO2). These recommendations are common but do not lie on high scientific knowledge and level of proof. In the major studies of these fifteen last years that changed ARDS management, PaO2 was kept around 85 and 90 mmHg despite current recommendations of 55 to 80 mmHg of PaO2.
Many recent review and cohort studies pointed the risk of excessive oxygenation especially following cardiac arrest, stroke or traumatic brain injury. However, these data come in majority from cohort or database study without strong definition of hyperoxia. Data coming from prospective studies are scarce and tend to show better outcome of patients with lower objectives of oxygenation in ICU.
High oxygen (O2) level may be deleterious especially on inflammatory lungs. It could enhance injuries due to mechanical ventilation. O2 could be responsable of " hyperoxia induced lung injury ".
The investigators showed in a precedent study that comparing a restrictive oxygenation versus a liberal oxygenation was feasable and do not expose patients to major adverse events. More, mortality at 60 days has tendency to be lower. The investigators therefore ask if a lower objectives of PaO2 in comparison with the level usually seen in last studies on ARDS could improve ARDS patients outcome.
The aim of this study is to show that a restrictive oxygenation in comparison with a liberal oxygenation strategy in patients with ARDS would lower mortality at 28 days.
It is a prospective, comparative, randomized, multicentric, french, open study. Patients with ARDS will be enrolled and will be allocated to Liberal Oxygenation arm (LO) or to Conservative Oxygenation arm (CO) during the invasive mechanical ventilation procedure in ICU.
In LO arm, objective of PaO2 is 90 to 105 mmHg. In CO arm, objective of PaO2 is 55 to 70 mmHg.
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Exclusion Criteria:
A modulation of inspired fraction of oxygen will be performed with an objective of PaO2 between 90 to 105 mmHg that will be checked on arterial blood gases (ABG). Between these measurements, SpO2 will be kept more or equal to 96 percent. Alarms will be set at 95 percent for SpO2.
Drug: Modulation of Inspired Fraction of Oxygen (FiO2)
A modulation of inspired fraction of oxygen will be performed with an objective of PaO2 between 55 to 70 mmHg that will be checked on arterial blood gases. Between these measurements, SpO2 will be kept between 88 and 92 percent. Alarms will be set between 87 and 93 percent for SpO2.
Drug: Modulation of Inspired Fraction of Oxygen (FiO2)
In the two groups, if patient is not in the range of arterial oxygen pressure (PaO2), Inspired Fraction of Oxygen (FiO2) will be modified from 5 percent if difference between target is less than 5 mmHg and from 10 percent if difference from target is higher. A new arterial blood gases (ABG) will be performed 30 minutes later to check for the oxygen target range. When ABG are performed, pulsed oxymetry is compared with arterial saturation (SaO2) to adapt survey. Between each ABG, FiO2 is modified from 5 percent to 5 percent each five minutes until reaching good pulsed oxygen saturation (SpO2) target (that can be modified in function of the comparison of arterial oxygen saturation (SaO2 and SpO2 with ABG). This management of FiO2 will be done until extubation of the patient.
Death
Time frame: Day 28
Death
Time frame: Day 90
Days free of mechanical ventilation in ICU
Time frame: Day 28
Sequential Organ Failure Assessment (SOFA) Score
Sepsis-related Organ Failure Score
Time frame: Day 0, 3 and 7
Score of morbidity
This score is based on three points: need for mechanical ventilation, need for Morbidity are renal replacement therapy, need of catecholamine or need for ventilation
Time frame: Day 28
Ventilator associated pneumonia
Time frame: Day 28
Septicemia
Time frame: Day 28
Antibiotic consumption
Number of days exposed to antibiotics divided by the number of days spent in ICU
Time frame: Day 28
Cardiovascular complications
New onset of rhythm disorders, cardiac ischemia and dose of catecholamin at 28 and 90 days
Time frame: Day 28 and day 90
Neurological evolution
Neurological evolution measured with daily Richmond Agitation Sedation Scale score, seizures, new stroke, daily sedation doses, neuroleptic administration
Time frame: Day 28
Respiratory autonomy
Need for oxygen or mechanical ventilation support
Time frame: Day 28 and 90
Plan to share: No
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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