Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients

NCT01363102 | Unknown DMC

• 1 other identifier: 11112010
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 5

Brief Summary

The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Additionally, the investigators hypothesize that genetic polymorphisms related to muscle strength and sleep will also explain some variance in these outcome variables.

Conditions

Muscle Weakness; Critical Illness; Respiratory Insufficiency

Keywords

Muscle strength; functional mobility; outcome; intensive care unit; quality of life

Outcome Measures

Primary Outcomes (1)

• Average achieved SOMS level

  Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.

  Average SOMS level from time to inclusion to ICU discharge readiness, an expected time of one to two weeks (expected time of one to two weeks).

Secondary Outcomes (6)

• SICU length of stay

  Patients will be followed until SICU discharge, an expected 2 days to 2 weeks

• The "mini" modified Functional Independence Measure (mmFIM) level

  mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively.

• Quality of life following hospital discharge

  three months after hospital discharge

• Muscle strength

  ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.

• Side effects of mobilization therapy

  during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.

Study Arms (2)

Control group

NO INTERVENTION

Group will undergo usual mobilization per standard SICU care

Study Group

EXPERIMENTAL

Patient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day.

Procedure: SOMS

Interventions

SOMS PROCEDURE

Apply a number to mobilization goal for patient

Also known as: Early Mobilization

Study Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years of age or greater)
• Who have been on mechanical ventilation for less than 48 hours and are expected to continue for at least 24 more hours
• Who meet criteria for baseline functional independence (Barthel Index greater than or equal to 70 obtained from a proxy describing patient function 2 weeks before admission

You may not qualify if:

• Irreversible disorders with 6-month mortality greater than 50%
• Rapidly developing neuromuscular disease
• Cardiopulmonary arrest
• Motor component of Glascow Coma Scale \<5
• Elevated intracranial pressure
• Ruptured/leaking aortic aneurysm
• Acute MI before peak troponin has been reached
• Absent lower limbs
• Pregnancy
• Unstable fractures contributing to likely immobility
• Hospitalization prior to ICU admission \>5 days
• Enrollment in another clinical trial

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• University of Massachusetts, Worcester: collaborator
• Technical University of Munich: collaborator
• University of Salzburg: collaborator

Study Sites (5)

The Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01605, United States

Location

University of Salzburg

Salzburg, A-5020, Austria

Location

Technische Universität München

München, Bavaria, D-81675, Germany

Location

Related Publications (3)

• 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

• 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 DERIVED

• Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M. Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.

  PMID: 23959756 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Critical Illness; Respiratory Insufficiency

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Matthias Eikermann, MD, PhD

  The Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Surgical Intensive Care Unit

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: June 1, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

DE (1); US (3); AU (1)