Clinical trial NCT04319822: Mobility, Functional Autonomy and Respiratory Function After Prolonged Stay in Intensive Care Unit
Official title: Mobility, Functional Autonomy and Respiratory Function After Prolonged Stay in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensive Care
Keywords: Intensive Care Unit
Prolonged Stay in Intensive Care Unit
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The hospital survival of patients hospitalized after prolonged stay in intensive care unit has improved however there are a loss of functional autonomy and an impaired of peripheral and respiratory muscle performance, what leads to an impairment life's quality. These sequels constitute the Post Intensive Care Syndrome (PICS).

The objective of this cohort is to describe the functional autonomy at 6 months of a prolonged stay in intensive care unit and to study the associations between functional autonomy and 1 / the biological data obtained from quadriceps biopsies / the trajectory of post-resuscitation care.

The primary endpoint is functional autonomy at 6 months of ICU stay, assessed by the Functional Independence Measure (FIM) score.

In order to take into account a rate of loss of sight we propose to include in this cohort 120 subjects during their stay in intensive care unit.

Detailed description: The hospital survival of patients hospitalized after prolonged stay in intensive care unit has improved however there are a loss of functional autonomy and an impaired of peripheral and respiratory muscle performance, what leads to an impairment life's quality. These sequels constitute the Post Intensive Care Syndrome (PICS). Incomplete understanding of the physiopathological mechanisms that allow the recovery of functional autonomy and the lack of consideration of post-intensive care pathway seems central to explain the contrasting results of therapeutic trials in this syndrome.

Incomplete understanding of the physiopathological mechanisms that allow the recovery of functional autonomy and the lack of consideration of post-intensive care pathway seems relevant to explain the contrasting results of therapeutic trials in this syndrome.

The objective of this cohort is to describe the functional autonomy at 6 months of a prolonged stay in intensive care unit and to study the associations between functional autonomy and 1 / the biological data obtained from quadriceps biopsies / the trajectory of post-resuscitation care

Patient at high risk of loss on functional autonomy, staying in the three intensive unit care participants will be recruited, if they present inclusion criteria and don't present exclusion criteria Inclusion criteria: - mechanical ventilation for at least 72 hours and extra-respiratory organ failure Exclusion criteria : neurological or psychiatric deficit preventing the performance of assessment tests, chronic ventilation on tracheotomy, bedridden patient or moribund

The primary endpoint is functional autonomy at 6 months of ICU stay, assessed by the Functional Independence Measure (FIM) score. The secondary endpoints are survival, peripheral and respiratory muscle performance, metabolic stress testing, biologic features associated with muscle regeneration (quadriceps biopsy in resuscitation (before and after) and one at M6) , the quality of life and the path of care post-resuscitation. The statistical analysis will make it possible to describe the population according to 3 groups of the same size according to the Tertiles of the FIM to M6. The analysis will look for variables associated with belonging to the "case" group: patients with the highest disability (last testeile of the FIM score) compared to "controls": patients with a less severe disability (first two tiertiles of the score) FIM). In order to take into account a rate of loss of sight we propose to include in this cohort 120 subjects during their stay in intensive care unit.

Progress: 2 visits are planned (ICU, M6 and monthly telephone interviews). The duration of the inclusions will be 30 months and the duration of the follow-up of the patients will be 6 months.

Prospect :

* identification of physiopathological and structural factors (post-ICU trajectory) associated with recovery of functional autonomy and respiratory and peripheral muscular performance at a distance from a stay in intensive care unit
* the design of a personalized interventional study in order to improve the functional autonomy

Eligibility criteria: Inclusion Criteria:

* mechanical ventilation for at least 72 hours and extra-respiratory organ failure

Exclusion Criteria:

* neurological or psychiatric deficit preventing the performance of assessment tests,
* chronic ventilation on tracheotomy, bedridden patient or moribund

Primary outcomes:
measure: Assessment of the functional autonomy of patient
timeFrame: 6 months
Secondary outcomes:
measure: Number of patient survival
timeFrame: 6 months
measure: Performance of peripheral and respiratory muscles
timeFrame: 6 months
measure: metabolic stress testing
timeFrame: 6 months
measure: Description of the Characterization of satellite cells responsible for muscle regeneration
timeFrame: up to 6 months
measure: Description of the Biochemical features of the peripheral muscles
timeFrame: up to 6 months
measure: Assessment of the patient Quality of life
timeFrame: up to 6 months
measure: Assessment of the post ICU medical care and social environement
timeFrame: up to 6 months
Other outcomes:
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