Effects of Mobility Dose in Surgical Intensive Care Unit Patients

NCT03196960 | Unknown

• 1 other identifier: 2016P002045
• Study Type: observational
• Target: 150
• Locations: 3 countries
• Sites: 3

Brief Summary

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).

Conditions

Sarcopenia; Muscle Weakness; Critical Illness

Keywords

Mobilization Therapy; Critical Illness; Muscle Strength; Functional Mobility; Outcome; Intensive Care Unit; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Rectus Femoris Muscle Cross Sectional Area

  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)

  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

  Patients will be followed until hospital discharge an expected 3 to 40 days.

• SICU length of stay

  Patients will be followed until SICU discharge, an expected 3 to 30 days.

• Hospital length of stay

  Patients will be followed until hospital discharge an expected 3 to 40 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Technical University of Munich: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Klinikum Rechts der Isar

Munich, Bavaria, 81675, Germany

RECRUITING

Università degli Studi di Brescia

Brescia, Lombardy, 25123, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 26655919 BACKGROUND

• 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.

  PMID: 27707496 BACKGROUND

• 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.

  PMID: 22976446 BACKGROUND

• 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.

  PMID: 2782256 BACKGROUND

• 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.

  PMID: 22067629 BACKGROUND

• 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.

  PMID: 27015233 BACKGROUND

• 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.

  PMID: 33416257 DERIVED

MeSH Terms

Conditions

Sarcopenia; Muscle Weakness; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes; Disease Attributes

Study Officials

• Matthias Eikermann, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Eikermann, MD PhD

CONTACT

(617) 726-3030; meikermann@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia, Harvard Medical School; Clinical Director, Critical Care Division

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 23, 2017
• Study Start: May 22, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); US (1); DE (1)