Clinical examination, critical care ultrasonography and outcomes in the critically ill: cohort profile of the Simple Intensive Care Studies-I

Abstract

PurposeIn the Simple Intensive Care Studies-I (SICS-I), we aim to unravel the value of clinical and haemodynamic variables obtained by physical examination and critical care ultrasound (CCUS) that currently guide daily practice in critically ill patients. We intend to (1) measure all available clinical and haemodynamic variables, (2) train novices in obtaining values for advanced variables based on CCUS in the intensive care unit (ICU) and (3) create an infrastructure for a registry with the flexibility of temporarily incorporating specific (haemodynamic) research questions and variables. The overall purpose is to investigate the diagnostic and prognostic value of clinical and haemodynamic variables.ParticipantsThe SICS-I includes all patients acutely admitted to the ICU of a tertiary teaching hospital in the Netherlands with an ICU stay expected to last beyond 24 hours. Inclusion started on 27 March 2015.Findings to dateOn 31 December 2016, 791 eligible patients fulfilled our inclusion criteria of whom 704 were included. So far 11 substudies with additional variables have been designed, of which six were feasible to implement in the basic study, and two are planned and awaiting initiation. All researchers received focused training for obtaining specific CCUS images. An independent Core laboratory judged that 632 patients had CCUS images of sufficient quality.Future plansWe intend to optimise the set of variables for assessment of the haemodynamic status of the critically ill patient used for guiding diagnostics, prognosis and interventions. Repeated evaluations of these sets of variables are needed for continuous improvement of the diagnostic and prognostic models. Future plans include: (1) more advanced imaging; (2) repeated clinical and haemodynamic measurements; (3) expansion of the registry to other departments or centres; and (4) exploring possibilities of integration of a randomised clinical trial superimposed on the registry.Study registration numberNCT02912624; Pre-results.

The diagnostic accuracy of clinical examination for estimating cardiac index in critically ill patients: the Simple Intensive Care Studies-I

“…All patients were included within the first 24 h of their ICU admission and underwent clinical examination, immediately followed by CCUS. Patients were included by medical research interns and PhD students who had received a focused CCUS training course given by experienced cardiologist-intensivists (protocol in Supplements 1) [16]. These researchers were not involved in patient care, and their findings were not revealed to the patients' caregivers.…”

“…Our aim was to study the diagnostic performance of clinical examination in a twostep approach: to establish (1) which combination of clinical examination findings are independently associated with cardiac index and (2) the performance of clinical signs to diagnose a low or high cardiac index. The Simple Intensive Care Studies-I (SICS-I) was designed to assess the ability of clinical examination to estimate cardiac index and to identify patients with a low or high cardiac index [16].…”

Clinical examination findings as predictors of acute kidney injury in critically ill patients

“…Patient characteristics were registered at admission . All patients underwent clinical examination within 24 hours after ICU admission according to a prespecified protocol.…”

“…The SICS‐I was designed to address multiple hypotheses on six different outcomes and, therefore, the acute kidney injury outcome was adjusted for multiple hypothesis testing . We refer to our SAP for more details, but in short, a P ‐value of 0.015 indicated statistical significance and p‐values between 0.015 and 0.05 indicated suggestive significance with an increased family‐wise error rate .…”

Clinical examination: a trigger but not a substitute for hemodynamic evaluation

“…Curiously, Hiemstra et al [4] reported an unexpected similar failure rate in this study that included mostly medical patients. Even more surprising, Hiemstra et al [6] previously mentioned in their preliminary report of the first 704 included patients that echocardiography was judged by experts to be of sufficient quality in 632 patients (90%), a much more usual failure rate. The second interesting finding is that CI was frequently low in this unselected population of ICU patients.…”