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Liberal Oxygenation Versus Conservative Oxygenation in ARDS (LOCO2)

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ClinicalTrials.gov Identifier: NCT02713451
Recruitment Status : Unknown
Verified November 2018 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Intensive Care Drug: Modulation of Inspired Fraction of Oxygen (FiO2) Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liberal Oxygenation Versus Conservative Oxygenation in Patients With Acute Respiratory Distress Syndrome : Impact on Mortality (LOCO2 Study)
Actual Study Start Date : June 2016
Actual Primary Completion Date : May 31, 2019
Estimated Study Completion Date : September 28, 2019


Arm Intervention/treatment
Active Comparator: Liberal Oxygenation (LO) group
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)

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.


Experimental: Conservative Oxygenation (CO) group
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.





Primary Outcome Measures :
  1. Death [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Death [ Time Frame: Day 90 ]
  2. Days free of mechanical ventilation in ICU [ Time Frame: Day 28 ]
  3. Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Day 0, 3 and 7 ]
    Sepsis-related Organ Failure Score

  4. Score of morbidity [ Time Frame: Day 28 ]
    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

  5. Ventilator associated pneumonia [ Time Frame: Day 28 ]
  6. Septicemia [ Time Frame: Day 28 ]
  7. Antibiotic consumption [ Time Frame: Day 28 ]
    Number of days exposed to antibiotics divided by the number of days spent in ICU

  8. Cardiovascular complications [ Time Frame: Day 28 and day 90 ]
    New onset of rhythm disorders, cardiac ischemia and dose of catecholamin at 28 and 90 days

  9. Neurological evolution [ Time Frame: Day 28 ]
    Neurological evolution measured with daily Richmond Agitation Sedation Scale score, seizures, new stroke, daily sedation doses, neuroleptic administration

  10. Respiratory autonomy [ Time Frame: Day 28 and 90 ]
    Need for oxygen or mechanical ventilation support



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patients with mechanical ventilation
  • ARDS according to Berlin definition:Hypoxemia defined with PaO2 FiO2 ratio less or equal to 300 mmHg with Positive End Expiratory Pressure higher or equal to 5 cmH20, Less than seven days between a known clinical insult or new or worsening of respiratory symptoms, Bilateral opacities on chest Imaging not fully explained by effusions, lobar or lung collapse, or nodules, Respiratory failure not fully explained by cardiac failure or fluid overload
  • Less than twelve hours following initiation of mechanical ventilation.

Exclusion Criteria:

  • Pregnancy
  • Patient less than 18 years old
  • Sickle cell disease
  • Patient deprived of freedom, Under a legal protective measure
  • Cardiac arrest as the reason for ICU hospitalisation
  • Traumatic brain injury as the reason for ICU hospitalisation
  • Hemoptysis with embolization or surgery
  • Extracorporeal life support or Extracorporeal Membrane Oxygenation before randomization
  • Chronic Obstructive Pulmonary Disease with oxygen or non invasive ventilation at home (obstructive sleep apnoea syndrome is not an exclusion criteria)
  • Patient with very high risk of death with IGS II (Simplified Severity Index II) than 90
  • Indication of hyperbaric oxygenation : carbon monoxide intoxication, gas embolism, necrotizing fasciitis
  • Cyanide intoxication, methemoglobinemia
  • Untreated pneumothorax
  • Lymphangitis carcinomatosa
  • Eosinophilic pneumonia
  • Intensive care management for organ donation
  • Participation in another interventional study with mortality as a major outcome to avoid confounding factor
  • Patient not affiliated to social security

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713451


Locations
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France
BARROT Loïc
Besancon, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Loïc Barrot, MD BESANCON
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02713451    
Other Study ID Numbers: R/2015/52
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Oxygen
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury