Elsevier

The Lancet

Volume 388, Issue 10052, 1–7 October 2016, Pages 1377-1388
The Lancet

Articles
Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial

https://doi.org/10.1016/S0140-6736(16)31637-3Get rights and content

Summary

Background

Immobilisation predicts adverse outcomes in patients in the surgical intensive care unit (SICU). Attempts to mobilise critically ill patients early after surgery are frequently restricted, but we tested whether early mobilisation leads to improved mobility, decreased SICU length of stay, and increased functional independence of patients at hospital discharge.

Methods

We did a multicentre, international, parallel-group, assessor-blinded, randomised controlled trial in SICUs of five university hospitals in Austria (n=1), Germany (n=1), and the USA (n=3). Eligible patients (aged 18 years or older, who had been mechanically ventilated for <48 h, and were expected to require mechanical ventilation for ≥24 h) were randomly assigned (1:1) by use of a stratified block randomisation via restricted web platform to standard of care (control) or early, goal-directed mobilisation using an inter-professional approach of closed-loop communication and the SICU optimal mobilisation score (SOMS) algorithm (intervention), which describes patients’ mobilisation capacity on a numerical rating scale ranging from 0 (no mobilisation) to 4 (ambulation). We had three main outcomes hierarchically tested in a prespecified order: the mean SOMS level patients achieved during their SICU stay (primary outcome), and patient's length of stay on SICU and the mini-modified functional independence measure score (mmFIM) at hospital discharge (both secondary outcomes). This trial is registered with ClinicalTrials.gov (NCT01363102).

Findings

Between July 1, 2011, and Nov 4, 2015, we randomly assigned 200 patients to receive standard treatment (control; n=96) or intervention (n=104). Intention-to-treat analysis showed that the intervention improved the mobilisation level (mean achieved SOMS 2·2 [SD 1·0] in intervention group vs 1·5 [0·8] in control group, p<0·0001), decreased SICU length of stay (mean 7 days [SD 5–12] in intervention group vs 10 days [6–15] in control group, p=0·0054), and improved functional mobility at hospital discharge (mmFIM score 8 [4–8] in intervention group vs 5 [2–8] in control group, p=0·0002). More adverse events were reported in the intervention group (25 cases [2·8%]) than in the control group (ten cases [0·8%]); no serious adverse events were observed. Before hospital discharge 25 patients died (17 [16%] in the intervention group, eight [8%] in the control group). 3 months after hospital discharge 36 patients died (21 [22%] in the intervention group, 15 [17%] in the control group).

Interpretation

Early, goal-directed mobilisation improved patient mobilisation throughout SICU admission, shortened patient length of stay in the SICU, and improved patients’ functional mobility at hospital discharge.

Funding

Jeffrey and Judy Buzen.

Introduction

More than 5·7 million patients in the USA, and more than 2 million patients in Germany are treated annually in intensive care units, of which about one-third are admitted to these wards after an elective or emergency surgical procedure. Muscle weakness is as common as arterial hypotension in the surgical intensive care unit (SICU),1, 2, 3 and is predictive of adverse outcomes in critically ill patients.4, 5, 6, 7

Intensive care unit-acquired muscle weakness, a term describing several pathological entities with similar clinical features,3, 8 can be aggravated by immobilisation,3, 9, 10, 11 which is often prescribed in patients in the SICU as a by-product of a well established safety culture.12, 13 Mobilisation is often neglected, delayed, or done with subjective provider-specific efforts,14 due to scarcity of knowledge and available evidence. Because tools to measure the effect of early, goal-directed mobilisation therapy in the SICU were not available, as a first step our team created the SICU optimal mobilisation score (SOMS), a numerical rating scale ranging from 0 (no mobilisation) to 4 (ambulation), which describes patients’ mobilisation capacity. We validated SOMS in English, German, and Italian, as the basis to achieve early, goal-directed mobilisation therapy in the SICU.14, 15, 16, 17, 18

In this study we tested if early, goal-directed mobilisation, using a strict mobilisation algorithm combined with facilitated inter-professional communication, in critically ill SICU patients leads to improved mobility during SICU admission, decreased length of stay on the SICU, and increased functional independence at hospital discharge.

Section snippets

Study design

This trial was an international, multicentre, randomised controlled, clinical trial in SICUs of five university hospitals in Austria (Landeskrankenhaus Salzburg [Salzburg]), Germany (Klinikum rechts der Isar der Technischen Universität München [Munich]), and the USA (Beth Israel Deaconess Medical Center [Boston, MA], Massachusetts General Hospital [Boston, MA], and University of Massachusetts Medical Center [Worcester, MA]). The research protocol was approved by all participating centres’

Results

From July 1, 2011, to Nov 4, 2015, we randomly assigned 200 eligible adult patients to receive either standard treatment (96 [48%] patients; control group) or early, goal-directed mobilisation therapy (104 [52%] patients; intervention group; Figure 1, Figure 2). Seven (7%) patients in the intervention group were not included in the per-protocol population. Four patients voluntarily withdrew consent and three patients were not eligible (due to treatment plan being changed to comfort care) after

Discussion

Early, goal-directed mobilisation therapy in the SICU increased patients’ mobility level, decreased the length of stay in the SICU and hospital, and improved functional independence at hospital discharge.

Despite reports on the effectiveness of early mobilisation in medical ICU patients,30, 38, 39 early mobilisation during the first 3 days after admission to an ICU40 is not typically implemented in surgical patients.12, 13 Reasons as to why mobilisation is not used in patients in the SICU

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