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

Not Applicable

• Conditions: Muscle Weakness; Respiratory Insufficiency; Critical Illness
• Interventions: Procedure: SOMS

• Registration Number: NCT01363102
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

The trauma literature consistently shows that early mobilization improves patients' outcome after a localized trauma such as hip fracture, or blunt solid organ injuries. In addition, in critically ill patients on the medical ICU, early mobilization improves patients' functional outcome and decreases ICU length of stay (1). This study evaluates if critically ill patients in a surgical ICU can safely and effectively be mobilized early after trauma and surgery. The investigators propose to conduct a randomized controlled study in surgical intensive care unit patients to evaluate the effects of mSOMS guided early mobilization. Additionally, the study will examine known genetic polymorphisms as related to sleep quality and muscle strength and how it relates to early mobilization of surgical ICU patients. In particular, the study will focus on the following polymorphisms: CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes.

Study Timeline

• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-31
• Study Start: 2011-06
• Study First Posted: 2011-06-01
• Primary Completion: 2015-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Average achieved SOMS level	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).	Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.

Secondary Outcome Measures

Name	Time	Method
Muscle strength	ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.	Medical Research Council (MRC) scale.
SICU length of stay	Patients will be followed until SICU discharge, an expected 2 days to 2 weeks	Time from study inclusion to SICU discharge readiness, an expected time of one to two 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.	Using the modified Functional Independence Measure (mmFIM), the levels of the locomotion and transfer mobility domain at hospital discharge (4 point NRS) will be compared between groups.
Quality of life following hospital discharge	three months after hospital discharge	SF 36 score
Side effects of mobilization therapy	during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.	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. AE were also categorized by intensity as mild, moderate, or severe
Genetic Polymorphisms as related to the other outcomes	5 minutes to collect sample	Since Sleep duration has a genetic component corresponding to 40% heritability, we are going to conduct an analysis of known polymorphisms that are related to different variables of sleep quality and how it relates to muscle strength and mobility. In particular we will focus on polymorphisms in CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes, which are associated with sleepiness, sleep phase, inertia, and potentially with respiratory muscle weakness and duration.

Trial Locations

Locations (5)

The Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

University of Salzburg; 🇦🇹 Salzburg, Austria

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Technische Universität München; 🇩🇪 München, Bavaria, Germany