Mobility, Functional Autonomy and Respiratory Function After Prolonged Stay in Intensive Care Unit

NCT ID: NCT04319822

Last Updated: 2021-12-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2024-07-01

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

Conditions

Intensive Care

Keywords

Intensive Care Unit; Prolonged Stay in Intensive Care Unit

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

blood samples, muscular biopsy, and quality of life

quality of life, blood samples, quadriceps biopsy in intensive care unit (before and after the ICU hospitalization and one at M6

Group Type: EXPERIMENTAL

blood sample and muscular biopsy

Intervention Type: OTHER

blood sample and muscular biopsy

Interventions

blood sample and muscular biopsy

blood sample and muscular biopsy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Boris JUNG, MD,PhD

Role: CONTACT

Phone: 00467337736

Email: b-jung@chu-montpellier.fr

Other Identifiers

RECHMPL18_0465_7732

Identifier Type: -

Identifier Source: org_study_id