Overview

This trial is active, not recruiting.

Conditions muscle weakness, critical illness, respiratory insufficiency
Treatment soms
Sponsor Massachusetts General Hospital
Collaborator Beth Israel Deaconess Medical Center
Start date June 2011
End date July 2015
Trial size 200 participants
Trial identifier NCT01363102, 11112010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Group will undergo usual mobilization per standard SICU care
(Experimental)
Patient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day.
soms Early Mobilization
Apply a number to mobilization goal for patient

Primary Outcomes

Measure
Average achieved SOMS level
time frame: 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

Measure
SICU length of stay
time frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks
The "mini" modified Functional Independence Measure (mmFIM) level
time frame: 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
time frame: three months after hospital discharge
Muscle strength
time frame: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.
Side effects of mobilization therapy
time frame: during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.
Genetic Polymorphisms as related to the other outcomes
time frame: 5 minutes to collect sample

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients
Principal investigator Matthias Eikermann, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.