Clinical trial NCT05053724: Efficacy of the "Start to Move" Protocol on Functionality, Delirium and Acquired Weakness in ICU
Official title: Efficacy of the "Start to Move" Protocol on Functionality, Delirium and Acquired Weakness in ICU. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Intensive Care Unit Delirium
Intensive Care Neuropathy
Intensive Care Unit Syndrome
Mechanical Ventilation Complication
Keywords: Intensive Care Unit
Early mobilization
Physical therapy
ICU acquired weakness
Funcionality
Invasive mechanical ventilation
Lead sponsor: Hospital Felix Bulnes
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 69
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Methods: Randomized, single-blind, controlled clinical trial. Computational random assignment of the intervention using sealed envelopes (1:1), non-probabilistic, consecutive sampling of subjects admitted to Clínica Ensenada ICU between January 2018 - July 2019 and who met selection criteria.

Participants: All subjects admitted to Clínica Ensenada ICU, adults ≥15 years with invasive mechanical ventilation requirement \>48 hours were recruited. Subjects with neuromuscular disease; psychiatric history (attempted autolysis, schizophrenia, senile dementia or others, who due to their condition are not able to follow a logical sequential order, which could bias the evaluation and functional treatment); limb amputation; pregnancy; cardiorespiratory arrest with severe hypoxic-ischemic brain damage; total dependence prior to hospitalization, according to Barthel index (\<20 points); and not consenting to participate in the study were excluded.
Primary purpose: TREATMENT

Brief summary: Background: ICU hospitalization is associated with loss of strength, functionality and delirium. The "Start to Move protocol" demonstrated efficacy in improving and minimizing such effects.

Aim: To evaluate the effectiveness of the "Start to move protocol" compared with conventional treatment in ICU subjects on functionality, weakness acquired in the Intensive Care Unit (ICU-AW), incidence of delirium, days of invasive mechanical ventilation (IMV), ICU stay and 28-day mortality.

Methods: Randomized controlled clinical trial. Including adults ≥15 years with IMV \>48 hours, randomized into Start to move and conventional treatment groups.Functionality, ICU-AW incidence, delirium incidence, IMV days, ICU stay and mortality-28 days were analyzed.

Detailed description: Introduction:

Individuals hospitalized in Intensive Care Units are subjected to a prolonged state of rest and to various factors that directly or indirectly affect the muscular and organic structure, which can result in ICU-acquired weakness (ICU-AW) and a limitation in functional performance.

These factors can be divided into metabolic, pharmacological and organic, where sustained hyperglycemia, corticosteroid use, sedation-analgesia, neuromuscular blockade and multiorgan failure associated with sepsis or septic shock stand out. This state translates into a direct loss of muscle mass, specifically of type II fibers, physiologically explained by an increase in the myosin protein degradation process, a decrease in protein synthesis and an increase in proinflammatory cells that favor the weakness of the critically ill patient.

Brower et al. studied that the effects of prolonged rest produce a deconditioning and atrophy of the musculature. After 14 days of immobilization, young people and adults are exposed to a 9% loss of quadriceps muscle mass, which translates into a loss of muscle strength of up to 27%.In subjects subjected to invasive mechanical ventilation, it has been shown that the cross-sectional area of the quadriceps muscle can decrease up to 12.5% in the first week of their stay in the ICU, which can increase up to 15.7% if they present multiorgan failure versus a 3% loss in subjects with single organ failure.

ICU-AW and loss of function are also directly related to the prolonged use of sedoanalgesia, neuromuscular blockade and a higher incidence of delirium in the ICU. The presence of delirium is related to low participation in physical therapies, either by decreased cooperation and/or psychomotor agitation, thus directly influencing muscle status and subsequent functional recovery.

Brummel et al. report that delirium is common in the ICU, affecting between 60-80% of subjects undergoing IMV and between 20-50% of subjects on noninvasive mechanical ventilation, increasing the risk of removal of invasive elements, accidental extubations and the need for physical restraints that may delay the onset of functional recovery.

To demonstrate the consequences of prolonged rest and quantify ICU-AW, the Medical Research Council (MRC) assessment scale is used, a validated tool which analytically measures the strength of six muscle groups bilaterally with a score of 30 points per hemibody, obtaining a total of 60 points. A score of 48 points or less determines the presence of ICU-AW.

On the other hand, the validated Functional Status Scale - Intensive Care Unit (FSS-ICU), which measures functional milestones with a score between 0 and 35 points, is commonly used to assess the functionality of the critically ill patient 12.

The aim of our study is to evaluate the effectiveness of the Start to move protocol compared to conventional ICU treatment on functionality, ICU-Aw, incidence of delirium, days of mechanical ventilation, ICU stay and 28-day mortality, Clínica Ensenada 2018 - 2019.

Eligibility criteria: Inclusion Criteria:

* Subjects admitted to ICU
* Adults ≥15 years
* IMV requirement \>48 hours

Exclusion Criteria:

* Neuromuscular disease
* Psychiatric history (attempted autolysis, schizophrenia, senile dementia or others, who due to their condition are unable to follow simple orders, which could bias the assessment and functional treatment)
* Limb amputation
* Pregnancy
* Cardiorespiratory arrest with severe hypoxic-ischemic brain damage
* Total dependence prior to hospitalization, according to Barthel index (\<20 points);
* Subject without consenting to participate in the study.

Primary outcomes:
measure: Change of ICU-acquired weakness
timeFrame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
measure: Change of Functionality of the Critically Ill Patient (Intra-hospital)
timeFrame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
measure: Change of Functionality of the Critically Ill Patient (pre-hospitalization)
timeFrame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
measure: Change of Delirium
timeFrame: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Secondary outcomes:
measure: ICU stay (days)
timeFrame: It is measured in the 24 hours prior to discharge from the ICU.
measure: Days of invasive mechanical ventilation (IMV)
timeFrame: It is measured in the 24 hours prior to discharge from the ICU.
measure: Mortality at 28 days, post ICU discharge
timeFrame: Measured at 28 days post ICU discharge.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Sebastián Eduardo Soto López
state: Región Metropolitana
Study officials:
References:
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