Stefan J Schaller1, Matthew Anstey2, Manfred Blobner1, Thomas Edrich3, Stephanie D Grabitz4, Ilse Gradwohl-Matis5, Markus Heim1, Timothy Houle4, Tobias Kurth6, Nicola Latronico7, Jarone Lee8, Matthew J Meyer4, Thomas Peponis4, Daniel Talmor9, George C Velmahos10, Karen Waak11, J Matthias Walz12, Ross Zafonte13, Matthias Eikermann14. 1. Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany. 2. Department of Intensive Care, Sir Charles Gairdner Hospital, Nedlands, WA, Australia. 3. Department 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. 4. Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. 5. Universitätsklinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin, Universitätsklinikum Salzburg, Paracelsus Medical University, Salzburg, Austria. 6. Institute of Public Health, Charité, Universitätsmedizin Berlin, Berlin, Germany. 7. Department of Anesthesia, Critical Care and Emergency, Spedali Civili University Hospital, University of Brescia, Brescia, Italy. 8. Department 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. 9. Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. 10. Department of Trauma, Emergency Surgery, and Surgical Critical Care, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. 11. Department of Physical Therapy, Massachusetts General Hospital, Boston, MA, USA. 12. Department of Anesthesiology and Perioperative Medicine, University of Massachusetts Medical Center, Worcester, MA, USA. 13. Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Brigham, MA, USA; Women's Hospital and Harvard Medical School, Boston, MA, USA. 14. Department 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.
Abstract
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.
RCT Entities:
BACKGROUND: Immobilisation predicts adverse outcomes in patients in the surgical intensive care unit (SICU). Attempts to mobilise critically illpatients 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.
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