Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653998
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients A Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intensive Care Unit Acquired Weakness ICU-AW is a common complication of critical illnesses occurring in approximately 50 of ICU patients and is strongly associated with increased morbidity physical impairments and both short- and long-term mortality The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles however the clinical phenotype may differ depending on age disease burden length of ICU stay and mechanical ventilation duration
The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units This research is a multicentre prospective cohort study
The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units This research is a multicentre prospective cohort study
Detailed Description:
Prolonged immobilisation mechanical ventilation and sedation during critical illness have been associated with generalized muscle weakness restricted joint mobility pressure ulcers critical illness neuropathies or acquired weakness deep vein thrombosis DVT prolonged mechanical ventilation psychological disorders and cognitive impairment Barriers to early mobilisation have been identified including patient-related institution-related and physician-related barriers and various strategies have been used to overcome these barriers and facilitate the smooth practice of early mobilisation
Early mobilisation initiated within 24-48 hours of Intensive Care Unit ICU admission has been shown to be the best strategy for reducing ICU-acquired weakness ICUAW It includes a variety of interventions passive for non-cooperative patients eg positioning passive joint mobilisation and active-assisted or active for less or fully cooperative patients eg active or active-assisted joint mobilisation sitting on bed or chair transfers standing ambulation Several studies have provided evidence that progressive early mobilisation of adult ICU patients is feasible safe and can yield benefits including improved functional outcomes and reduced ICU and hospital stay durations
Successful implementation of an early physical rehabilitation program in most ICUs requires a structured process to promote quality improvement This involves a multidisciplinary approach including hospital administrators ICU and rehabilitation leaders who support the program and promote a culture change within the ICU It also requires assembling a multidisciplinary team including intensivists nursing clinical nutrition physical medicine and rehabilitation establishing a common goal and shared expectation of early rehabilitation for all patients with focused efforts to identify and overcome barriers to achieving this goal and obtaining basic equipment to facilitate early rehabilitation
Early mobilisation initiated within 24-48 hours of Intensive Care Unit ICU admission has been shown to be the best strategy for reducing ICU-acquired weakness ICUAW It includes a variety of interventions passive for non-cooperative patients eg positioning passive joint mobilisation and active-assisted or active for less or fully cooperative patients eg active or active-assisted joint mobilisation sitting on bed or chair transfers standing ambulation Several studies have provided evidence that progressive early mobilisation of adult ICU patients is feasible safe and can yield benefits including improved functional outcomes and reduced ICU and hospital stay durations
Successful implementation of an early physical rehabilitation program in most ICUs requires a structured process to promote quality improvement This involves a multidisciplinary approach including hospital administrators ICU and rehabilitation leaders who support the program and promote a culture change within the ICU It also requires assembling a multidisciplinary team including intensivists nursing clinical nutrition physical medicine and rehabilitation establishing a common goal and shared expectation of early rehabilitation for all patients with focused efforts to identify and overcome barriers to achieving this goal and obtaining basic equipment to facilitate early rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None