TY - JOUR
T1 - Early, goal-directed mobilisation in the surgical intensive care unit
T2 - a randomised controlled trial
AU - for the International Early SOMS-guided Mobilization Research Initiative
AU - Schaller, Stefan J.
AU - Anstey, Matthew
AU - Blobner, Manfred
AU - Edrich, Thomas
AU - Grabitz, Stephanie D.
AU - Gradwohl-Matis, Ilse
AU - Heim, Markus
AU - Houle, Timothy
AU - Kurth, Tobias
AU - Latronico, Nicola
AU - Lee, Jarone
AU - Meyer, Matthew J.
AU - Peponis, Thomas
AU - Talmor, Daniel
AU - Velmahos, George C.
AU - Waak, Karen
AU - Walz, J. Matthias
AU - Zafonte, Ross
AU - Eikermann, Matthias
N1 - Funding Information:
SJS reports holding stocks of the following companies in the health-care sector: Siemens AG, GE Healthcare, and Rhoen-Klinikum AG; and previously held stock in Bayer AG, Merck & Co Inc, and Fresenius SE. However, these holdings have not affected any decisions regarding this study. MB reports personal fees from Merck Sharp & Dohme and GlaxoSmithKline, outside the submitted work. TH reports personal fees from Depomed Inc, outside the submitted work. TK reports other from the British Medical Journal, Cephalalgia, and International Headache Society, and grants and personal fees from Massachusetts General Hospital, outside the submitted work. JL reports grants from La Jolla Pharmaceuticals, and personal fees from Butterfly Network Inc, outside the submitted work. ME reports grants from Jeff and Judy Buzen, during the conduct of the study, and grants from Merck & Co Inc and ResMed Foundation, outside the submitted work. MA, TE, SDG, IG-M, MH, NL, MJM, TP, DT, GCV, KW, JMW, and RZ declare no competing interests.
Publisher Copyright:
© 2016 Elsevier Ltd
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
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U2 - 10.1016/S0140-6736(16)31637-3
DO - 10.1016/S0140-6736(16)31637-3
M3 - Article
C2 - 27707496
AN - SCOPUS:84994850966
SN - 0140-6736
VL - 388
SP - 1377
EP - 1388
JO - The Lancet
JF - The Lancet
IS - 10052
ER -