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
The LTO-BLOXY study will compare respiratory, cognitive and exercise function outcomes in patients who underwent one of the two oxygenation strategies in the context of the on-going LOCO-2 study: * Experimental group: oxygenation will be maintained at a level between 55 and 70 mmHg of PaO2 as measured by blood gas test ("conservative" oxygenation). Between blood gas measures, oxygenation will be optimized to achieve an SpO2 between 88% and 92%. * Control group: oxygenation will be maintained at a level between 90 and 105 mmHg of PaO2 as measured by blood gas test ("liberal" oxygenation). Between blood gas measures, oxygenation will be optimized to achieve an SpO2 \>96%. The primary objective is to demonstrate a lower level of impairment of respiratory function at 6 months in survivors of acute respiratory distress syndrome (ARDS) after a "conservative" oxygenation strategy, as compared to a "liberal" oxygenation strategy. Secondary objectives are numerous and will explore different areas such as evalution of disability, respiratory function, exercise function, cognitive function and quality of life. Participation in the LTO-BLOXY study will be proposed to all patients included in LOCO-2 at discharge from the ICU. A total of 259 patients from the overall total of 850 expected inclusions in LOCO-2, will participate in the LTO-BLOXY study. These patients will be followed up to 1 year after their initial inclusion in LOCO-2, with a view to evaluate respiratory function, exercise function and cognitive function, as well as QoL. The calendar of their study participation is as follows: * Inclusion in LOCO-2 study and randomization LOCO-2 * Inclusion in LTO-BLOXY study at discharge from the ICU * 3 month visit ± 2 weeks (3 months after inclusion in LOCO-2 study) * 6 month visit ± 2 weeks (6 months after inclusion in LOCO-2 study) * 12 month visit ± 2 weeks (12 months after inclusion in LOCO-2 study) At each follow-up visit, the patient will attend a consultation in the Department of Physiology - Functional Explorations, where the study questionnaires will be given to the patient for completion. The neuropsychologist will perform the cognitive tests, the respiratory function and exercise tests will also be performed at the same visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
259
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.
CHU de Besançon
Besançon, France
RECRUITINGDiffusing Capacity of the Lungs for carbon monoxide (DLCO)
The primary endpoint is the diffusing capacity of the lungs for carbon monoxide (DLCO), a measure that reflects disorders in pulmonary gas volume, the alveolar-capillary membrane, and the volume of blood in the lung capillaries
Time frame: 6 months
Evaluation of disability (Functional Independence Measure)
FIM scale to assess the patient's performance in the activities of daily living, including cognitive and relational aspects.
Time frame: inclusion, 6 months
A binary composite morbi-mortality variable
A binary composite morbi-mortality variable defined as follow: * Failure: death or poor FIM * Success: alive and good recuperation
Time frame: 6 months, 12 months
Respiratory function: plethysmography
Total lung capacity and functional residual capacity measured by plethysmography
Time frame: 3 months, 6 months, 12 months
Respiratory function
FEV1 and FEV1/FVC ratio
Time frame: 3 months, 6 months, 12 months
Respiratory function: blood gases
PaO2 and PaCO2 measured in room air at rest
Time frame: 3 months, 6 months, 12 months
Respiratory function: inspiratory pressure
Sniff nasal inspiratory pressure (SNIP) and maximal inspiratory pressure (PImax) (diaphragm function).
Time frame: 3 months, 6 months, 12 months
Exercise function: 6-min walk test
distance covered during a 6-minute walk test, in meters
Time frame: 3 months, 6 months, 12 months
Exercise function: cyclo ergometer
Physiological parameters measured at peak effort limited by symptoms on a bicycle ergometer exercise test
Time frame: 6 months
Cognitive function: screening tests
Cognitive function will be investigated firstly through the use of rapid screening tests
Time frame: inclusion, 3 months
Cognitive function
Cognitive function will be investigated secondly through an evaluation performed by a neuropsychologist through the use of the RAPID battery
Time frame: 12 months
Quality of life: The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
The SF36, in its validated French language version, is an established instrument used to evaluate quality of life (QoL).The questionnaire yields an overall score between 0 and 100, with a higher score indicating better QoL.
Time frame: 3 months, 6 months, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.