Long Term Outcome on Brain and Lung of Different Oxygen Strategies in ARDS Patients

• Status: Unknown status
• Trial end date: 2021-09-20
• Target enrollment: 0
• Participant gender: All

Summary

Acute respiratory distress syndrome (ARDS) is a serious disease with high mortality. In patients who survive ARDS, respiratory, neurological and motor sequelae are frequent, negatively impacting on the patient's quality of life, and engendering substantial healthcare costs (rehabilitation, long-term care, delayed return to work). There may also be repercussions on the patient's family and entourage. The severity of ARDS and the burden it represents have underpinned intensive research to identify treatment strategies that could improve mortality. However, it is important to ensure that any improvement in mortality does not come at the price of an excess of sequelae and disability in survivors.

The oxygenation strategy used to treat ARDS may have an impact on mortality in these patients. The CLOSE study, in which our group participated, recently demonstrated the feasibility of two oxygenation strategies in intensive care unit (ICU) patients with ARDS. We have also initiated the LOCO-2 study (NCT02713451), whose aim is to show a reduction in mortality in ARDS using a "conservative" oxygenation strategy (PaO2 maintained between 55 and 70 mmHg) as compared to a classical "liberal" oxygenation strategy (PaO2 between 90 and 105 mmHg).

The LTO-BLOXY study is a substudy of the on-going LOCO-2 study

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Criteria

Inclusion Criteria:

• ARDS defined as a PF ratio <300

• Patients under ventilation for <12 hours

• Stabilization period of 3 hours with standardization of ventilation parameters

Inclusion criterion specific for neurological evaluation:

• Patient aged between 20 and 89 years

Exclusion Criteria:

• Chronic respiratory failure or on home ventilation (excluding obstructive sleep apnoea)

• Cardiac arrest

• Moribund patients (death likely within 48 hours as assessed by the ICU physician)

• Gaseous embolism

• CO poisoning

• Pregnant women

• Indication for hyperbaric oxygen treatment

• Persistent pneumothorax

• Gaseous gangrene

• DNR or limited care order

Exclusion criteria specific for neurological evaluation:

• History of neurological disorders: cranial trauma, stroke, cerebral tumor, epilepsy, neuro-degenerative disease.

• Psychiatric disorders: bipolar disorder, psychosis, addiction, schizophrenia.

• Lack of autonomy due to previously documented cognitive and/or psychomotor impairment.

• Hearing and/or sight impairment that prevent the patient from performing the study tests

Patients presenting exclusion criteria for the neurological evaluation can nonetheless be included in the study for the evaluation of respiratory function.