Effects of Mobility Dose in Surgical Intensive Care Unit Patients

Study Overview
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Brief Summary
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The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).

Detailed Description
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Our research group aims to better understand how patients on the SICU are mobilized and the impact it has on adverse discharge disposition and functional outcome after hospital discharge. We have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of SICU patients (NCT01363102). In addition, we have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502). In this study we measure the dose of mobility, defined as a function of both the mobility provided by nursing and physical therapists (e.g., sitting at the edge of the bed, ambulating) as well as its duration. We will build on an existing mobility intensity quantification tool (NCT01674608) and add a domain that quantifies its duration in order to obtain a broad picture of the mobilization of patients on the SICU. The mobility dose is expressed by the mobility quantification score that has been developed by our team. We will then test the hypotheses that mobilization dose in the ICU predicts discharge disposition, defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility; or in-hospital mortality. Further we will evaluate the association between mobility dose and cross sectional area of the rectus femoris muscle measured by bedside ultrasound as a potential reflection of ICU-acquired muscle weakness (exploratory outcome). Mobilization Quantification score: MQS (Detailed table linked in reference section) This score integrates the highest rated activities within each mobility session - from physical therapy and nursing. By multiplying the scale it gets greater and allows a better interpretation of mobility intensity. It adds value of mobility dose across sessions considering the entire spectrum of active participation of the patient over the day. Some specifics: If patient achieves a level in between predefined MQS levels we score the closest lower level We collect mobility data for the night time by interviewing the day nurses and asking them about the patients' mobilization also during night time We round up the duration of each mobility session: Passive range of motion (PRM) conducted 4 times during the day counts as: 1*4=4 (corresponding to 4 units/hours) For each session, we calculate the highest mobility level for the duration of the mobility session: e.g. Patient is standing for 5 minutes before s/he walks with 2 assists for 10 minutes: 3*7=21 (adding up the duration of various activities within a session and multiplying it by the highest achieved mobility level). Sitting passively in the chair is an exception (see below). Sitting: Sitting in the chair counts as a separate session. Per sitting session a maximum of 2 hours are counted. For example: if a patient was sitting for a duration of either 2, 4 or 5 hours, we would always count: 2*4=8 For patients stepping/shuffling/walking to the chair we use level 5 every time the patient is doing it. E.g. patient is shuffling to the chair, sitting for 2 hours and then walking back: 5*1+2*4+5*1 =28 Distinct sitting sessions are defined by the patient being back in bed in between the sessions of sitting in the chair. E.g. the patient gets actively to chair by stand-step/shuffle, sits in chair for 6 hours, during sitting session patient gets up twice and afterwards gets back to bed by stand-step/shuffle: 5*1(to chair)+2*4(sitting)+5*1(back to bed)+5*2(standing up 2x in between)=28

Official Title
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Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition

Conditions
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Sarcopenia, Muscle Weakness, Critical Illness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18 years of age or greater) Barthel score ≥70 from a proxy describing patient function 2 weeks before admission Expected stay on the ICU of >=3 days Exclusion Criteria: Patients transferred from other hospitals, long-term rehabilitation facilities or nursing homes with a preceding stay of more than 48 hours Hospitalization 1 month prior to ICU admission >7 days Discussion about changing the goals of care from cure to comfort High risk of persistent brain injury (GCS<5 motor component and presence of TBI) Patients with neurodegenerative diseases Subjects with absence of a lower extremity Patients with paraplegia or tetraplegia Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Hospital Discharge Disposition | Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality. | Patient will be followed until hospital discharge, an expected 3 to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectus Femoris Muscle Cross Sectional Area | Rectus femoris cross sectional area will be measured by bedside ultrasound | Rectus femoris cross sectional area will be measured twice, at enrollment and day of ICU discharge, an expected 3 to 30 days. | 
| Mobility Dose as measured by the Mobilization Quantification Score (MQS) | Mobilization Quantification Score (MQS) is a composition of the validated ICU mobility score, a 0 to 10 value scale that measures the mobility milestones in critically ill patients, multiplied by a for each level previously defined time unit (5 or 30 minutes correspond to one unit). | Patients will be followed until SICU discharge, an expected 3 to 30 days. | 
| Abbreviated Functional independence measure (FIM) score at Surgical Intensive Care Unit (SICU) discharge and hospital discharge | Abbreviated FIM score obtained by physical therapy (PT) within 48 hours of discharge, and by research assistant on the day of discharge if the subject was not seen by PT in the indicated time period. | Patients will be followed until hospital discharge an expected 3 to 40 days. | 
| SICU length of stay | Number of days from SICU admission to SICU discharge | Patients will be followed until SICU discharge, an expected 3 to 30 days. | 
| Hospital length of stay | Number of days from hospital admission to hospital discharge | Patients will be followed until hospital discharge an expected 3 to 40 days. | 
| SICU Ventilator-free days | Number of days spent on the SICU that patient is not receiving mechanical ventilation. | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 
| SICU Vasopressor-free days | Number of days spent on the SICU that patient is not receiving any vasopressor medications. | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 
| SICU Delirium-free days | Days spent on the SICU that patient is Confusion assessment method (CAM)-ICU/Richmond Agitation-Sedation Scale (RASS) negative. | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 
| SICU Neuromuscular Blocking drug-free days | Number of days spent on the ICU that patient is not receiving Neuromuscular Blocking Agents | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 
| Opioid Use | Opioid dose administered, calculated as morphine equivalent dose. | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 
| Corticosteroid Days | Number of day on ICU with corticosteroid administration Number of day on ICU with corticosteroid administration Number of ICU days with corticosteroid administration | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 
| Physical Work Capacity | Obtained after hospital discharge, measured by the Duke Activity Status Index (DASI) | Measured three months after hospital discharge | 
| 3-Month Mortality |  | Evaluated three months after hospital discharge | 
| Falls | Number of Falls during ICU stay | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 
| Side effects of mobilization therapy | Number of unfavorable signs and symptoms or unintended deterioration of clinical status associated with mobilization therapy, including, but not limited to, unplanned extubation or dislodgment of drains, arterial catheters, venous devices, or other medical equipment. The relationship of any untoward event to mobilization therapy was assessed by the clinician and reported as unrelated, unlikely, possibly, or definitely related. Adverse events (AE) were also categorized by intensity as mild, moderate, or severe | Patients will be followed until ICU discharge, an expected 3 to 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Mobilization Therapy, Critical Illness, Muscle Strength, Functional Mobility, Outcome, Quality of Life