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Influence of the initial level of consciousness on early, goal-directed mobilization: a post hoc analysis

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Abstract

Purpose

Early mobilization within 72 h of intensive care unit (ICU) admission improves functional status at hospital discharge. We aimed to assess the effectiveness of early, goal-directed mobilization in critically ill patients across a broad spectrum of initial consciousness levels.

Methods

Post hoc analysis of the international, randomized, controlled, outcome-assessor blinded SOMS trial conducted 2011–2015. Randomization was stratified according to the immediate post-injury Glasgow Coma Scale (GCS) (≤ 8 or > 8). Patients received either SOMS-guided mobility treatment with a facilitator or standard care. We used general linear models to test the hypothesis that immediate post-randomization GCS modulates the intervention effects on functional independence at hospital discharge.

Results

Two hundred patients were included in the intention-to-treat analysis. The significant effect of early, goal-directed mobilization was consistent across levels of GCS without evidence of effect modification, for the primary outcome functional independence at hospital discharge (p = 0.53 for interaction), as well as average achieved mobility level during ICU stay (mean achieved SOMS level) and functional status at hospital discharge measured with the functional independence measure. In patients with low GCS, delay to first mobilization therapy was longer (0.7 ± 0.2 days vs. 0.2 ± 0.1 days, p = 0.008), but early, goal-directed mobilization compared with standard care significantly increased functional independence at hospital discharge in this subgroup of patients with immediate post-randomization GCS ≤ 8 (OR 3.67; 95% CI 1.02–13.14; p = 0.046).

Conclusion

This post hoc analysis of a randomized controlled trial suggests that early, goal-directed mobilization in patients with an impaired initial conscious state (GCS ≤ 8) is not harmful but effective.

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Funding

This study was funded by an unrestricted grant from Jeff and Judy Buzen to Matthias Eikermann. The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and the decision to submit the manuscript for publication.

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    Authors and Affiliations

    1. Department of Anesthesiology and Intensive Care, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany

      Stefan J. Schaller, Franziska Krebs & Manfred Blobner

    2. Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

      Flora T. Scheffenbichler, Hao Deng, Stephanie D. Grabitz & Timothy Houle

    3. Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA

      Somnath Bose & Matthias Eikermann

    4. Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

      Nicole Mazwi

    5. Department of Neurology, Klinikum Rechts Der Isar, School of Medicine, Technical University of Munich, Munich, Germany

      Christian L. Seifert

    6. Department of Surgery, Boston University, Boston, MA, USA

      George Kasotakis

    7. Department of Anesthesia, Critical Care and Emergency Medicine, Spedali Civili University Hospital, University of Brescia, Brescia, Italy

      Nicola Latronico

    8. Essen-Duisburg University, Medical Faculty, Essen, Germany

      Matthias Eikermann

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    1. Stefan J. Schaller
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    Contributions

    Study concept and design: MB, ME, SJS. Acquisition, analysis or interpretation of data: All authors. Drafting of the manuscript: SJS and ME. Revising the manuscript critically for important intellectual content: All authors. Statistical analysis: MB, HD, TH, SJS, FTS. Final approval of the version to be published: All authors. ME had full access to all the data in the study and is the guarantor for the integrity of the data and the accuracy of the data analysis.

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    Correspondence to Matthias Eikermann.

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    Conflicts of interest

    Stefan J. Schaller received research support from MSD (Haar, Germany) not related to this manuscript. He holds stocks from Rhoen-Klinikum, Bayer AG and Siemens AG and held stocks in the recent past from GE Healthcare, Merck and Co., Inc., and Fresenius SE. These holdings have not affected any decisions regarding his research or this study. Flora T. Scheffenbichler reports no disclosures. Nicole Mazwi reports no disclosures. Hao Deng reports no disclosures. Franziska Krebs reports no disclosures. Christian L. Seifert reports no disclosures. George Kasotakis reports no disclosures. Stephanie D Grabitz reports no disclosures. Nicola Latronico reports no disclosures. Somnath Bose reports no disclosures. Timothy Houle reports no disclosures. Manfred Blobner received research support from MSD (Haar, Germany) not related to this manuscript; he received honoraria for lectures from GE Healthcare (Helsinki, Finland) and Grünenthal (Aachen, Germany). Matthias Eikermann received research support from Merck not related to this manuscript; he also received research support for this study from Jeff and Judy Buzen.

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    For this analysis was obtained by the institutional review board of Massachusetts General Hospital (protocol number 2016P002199) and registered at Clinical Trials (NCT03666338).

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    Stefan J. Schaller and Flora T. Scheffenbichler made equal contributions to the study.

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    Schaller, S.J., Scheffenbichler, F.T., Bose, S. et al. Influence of the initial level of consciousness on early, goal-directed mobilization: a post hoc analysis. Intensive Care Med 45, 201–210 (2019). https://doi.org/10.1007/s00134-019-05528-x

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