Evidence map›Paper›PMID 27707496›Full record

Trial reportLancet (London, England)2016

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

Stefan J Schaller, Matthew Anstey, Manfred Blobner, Thomas Edrich, Stephanie D Grabitz, Ilse Gradwohl-Matis, Markus Heim, Timothy Houle, Tobias Kurth, Nicola Latronico and 10 more

5 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 307 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
307citing papers in PubMed, 21 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01363102 naunknown statusnot on this map

Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients

TypeinterventionalSponsorMassachusetts General HospitalRan2011 to 2016Enrolled200ConditionsMuscle Weakness, Critical Illness, Respiratory InsufficiencyArmsSOMS
NCT03196960 unknown statusnot on this mapstarted 2017, after this paper: background citation

Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition

TypeobservationalSponsorMassachusetts General HospitalRan2017 to 2018Enrolled150ConditionsSarcopenia, Muscle Weakness, Critical Illness
NCT03347656 completednot on this mapstarted 2017, after this paper: background citation

Effects of Mobility Dose on Discharge Disposition in Critically Ill Stroke Patients

TypeobservationalSponsorBeth Israel Deaconess Medical CenterRan2017 to 2021Enrolled164ConditionsSarcopenia, Stroke, Acute, Muscle Weakness, Critical Illness
NCT03666338 nacompletednot on this map

Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization

TypeinterventionalSponsorTechnical University of MunichRan2011 to 2016Enrolled200ConditionsCritical Care, RehabilitationArmsEarly, goal-directed mobilization
NCT06532994 recruitingnot on this mapstarted 2024, after this paper: background citation

Development and Validation of a Prediction Algorithms to Estimate the Clinical Effect of Early Rehabilitation on ICU Survivors Received Mechanical Ventilation in the ICU

TypeobservationalSponsorWuhan UniversityRan2024 to 2026Enrolled250ConditionsIntensive Care, Mechanical Ventilation, Rehabilitation, AlgorithmsArmsEarly rehabilitation intervention
3 · Its place in the literature

Who cites it

307 citing papers in PubMed, 21 syntheses or guidelines pooled it.

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247 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Stefan J SchallerKlinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
Matthew AnsteyDepartment of Intensive Care, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.
Manfred BlobnerKlinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
Thomas EdrichDepartment of Anesthesiology and Critical Care, Klinikum Landkreis Erding, Erding, Germany; Universitätsklinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin, Universitätsklinikum Salzburg, Paracelsus Medical University, Salzburg, Austria.
Stephanie D GrabitzDepartment of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Ilse Gradwohl-MatisUniversitätsklinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin, Universitätsklinikum Salzburg, Paracelsus Medical University, Salzburg, Austria.
Markus HeimKlinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
Timothy HouleDepartment of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Tobias KurthInstitute of Public Health, Charité, Universitätsmedizin Berlin, Berlin, Germany.
Nicola LatronicoDepartment of Anesthesia, Critical Care and Emergency, Spedali Civili University Hospital, University of Brescia, Brescia, Italy.
Jarone LeeDepartment of Trauma, Emergency Surgery, and Surgical Critical Care, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, USA.
Matthew J MeyerDepartment of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Thomas PeponisDepartment of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Daniel TalmorDepartment of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
George C VelmahosDepartment of Trauma, Emergency Surgery, and Surgical Critical Care, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Karen WaakDepartment of Physical Therapy, Massachusetts General Hospital, Boston, MA, USA.
J Matthias WalzDepartment of Anesthesiology and Perioperative Medicine, University of Massachusetts Medical Center, Worcester, MA, USA.
Ross ZafonteDepartment of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Brigham, MA, USA; Women's Hospital and Harvard Medical School, Boston, MA, USA.
Matthias EikermannDepartment of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Universität Duisburg-Essen, Klinik für Anaesthesiologie und Intensivmedizin, Essen, Germany. Electronic address: meikermann@partners.org.
International Early SOMS-guided Mobilization Research Initiative

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmobilisation 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.

methodsWe 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).

findingsBetween 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).

interpretationEarly, 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.

fundingJeffrey and Judy Buzen.

Indexed as

Early AmbulationPatient Care PlanningPhysical Therapy ModalitiesAgedAlgorithmsAustriaConfounding Factors, EpidemiologicCritical CareFemaleGermanyHumansIntensive Care UnitsMaleMiddle AgedReproducibility of ResultsResearch Design

Identifiers

PMID27707496

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.