Effects of Mobility Dose in Surgical Intensive Care Unit Patients (MQS)

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

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).

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Muscle Weakness; Sarcopenia

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Recruiting
      • Klinikum rechts der Isar
      • Contact: Stefan Schaller, MD
• Italy
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • Recruiting
      • Universita degli Studi di Brescia
      • Contact: Nicola Latronico, MD
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Matthias Eikermann, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients recovering in an intensive care unit following a trauma or a surgical procedure

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Technical University of Munich; Università degli Studi di Brescia
• Investigators: Principal Investigator: Matthias Eikermann, MD PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
• Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.
• Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.
• Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
• Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
• Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.
• Scheffenbichler FT, Teja B, Wongtangman K, Mazwi N, Waak K, Schaller SJ, Xu X, Barbieri S, Fagoni N, Cassavaugh J, Blobner M, Hodgson CL, Latronico N, Eikermann M. Effects of the Level and Duration of Mobilization Therapy in the Surgical ICU on the Loss of the Ability to Live Independently: An International Prospective Cohort Study. Crit Care Med. 2021 Mar 1;49(3):e247-e257. doi: 10.1097/CCM.0000000000004808.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2017
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (ACTUAL): June 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Intensive Care Unit; Critical Illness; Outcome; Muscle Strength; Functional Mobility; Mobilization Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Muscle Weakness; Sarcopenia; Critical Illness
• Other Study ID Numbers: 2016P002045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Scoring Sheet
   Information comments: Mobilization Quantification Score

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No