Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial

Abstract

OBJECTIVE: To describe the protocol and statistical analysis plan for the Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. DESIGN: An international, multicentre, parallel-group, randomised controlled phase 3 trial. SETTING: Intensive care units (ICUs) in Australia, New Zealand, Germany, Ireland, the United Kingdom and Brazil. PATIENTS: 750 adult patients expected to receive mechanical ventilation for more than 48 hours. INTERVENTIONS: Early activity and mobilisation delivered to critically ill patients in an ICU for up to 28 days compared with standard care. MAIN OUTCOME MEASURES: The primary outcome is the number of days alive and out of hospital at 180 days after randomisation. Secondary outcomes include ICU-free days, ventilator-free days, delirium-free days, all-cause mortality at 28 and 180 days after randomisation, and functional outcome at 180 days after randomisation. RESULTS: Recruitment at 46 research sites passed 576 patients in March 2021. Final collection of all 180-day outcome data for the target of 750 patients is anticipated by May 2022. CONCLUSIONS: Consistent with international guidelines, a detailed protocol and prospective analysis plan has been developed for the TEAM III trial. This plan specifies the statistical models for evaluating primary and secondary outcomes, defines covariates for adjusted analyses, and defines methods for exploratory analyses. Application of this protocol and statistical analysis plan to the forthcoming TEAM III trial will facilitate unbiased analyses of the clinical data collected. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03133377.

Mobilisation of critically ill patients receiving norepinephrine: a retrospective cohort study

“…out-of-bed active mobilisation only; therefore, the more conservative approach seems reasonable. The largest international mobilisation trial (TEAM RCT) used a combined noradrenaline/adrenaline infusion rate of ≤ 0.2 µg/kg/min, or if there was an increase by more than 25% in the last 6 h, the dose had to be < 0.1 µg/kg/min [ 22 ].…”

“…Although the assistance is mostly carried out by one person, we took a conservative approach and assigned an IMS of 7 in those cases. The highest achieved IMS level of one mobilisation session was used as described [ 11 , 22 ].…”

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“…[7][8][9][10] This is because they highlight the role that our two countries have had and continue to have in evidence-based medicine. In this issue, we present both the TEAM trial 11 and BLING III trial protocols. 12 Assessment of quality of care and performance and safety are also part of the intensive care community 13 and are highlighted by articles on hospital-acquired complications of critical illness, 14 interhospital transport of sick children, 15 and assessment of ICU activity and strain.…”

In this issue of CCR

“… 7 , 8 , 9 , 10 This is because they highlight the role that our two countries have had and continue to have in evidence-based medicine. In this issue, we present both the TEAM trial 11 and BLING III trial protocols. 12 …”