Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

Abstract

Longitudinal evaluations of critically ill patients by combinations of clinical examination, biochemical analysis and critical care ultrasonography (CCUS) may detect adverse events of interventions such as fluid overload at an early stage. The Simple Intensive Care Studies (SICS) is a research line that focuses on the prognostic and diagnostic value of combinations of clinical variables. The SICS-I specifically focused on the use of clinical variables obtained within 24 h of acute admission for prediction of cardiac output (CO) and mortality. Its sequel, SICS-II, focuses on repeated evaluations during ICU admission. The first clinical examination by trained researchers is performed within 3 h after admission consisting of physical examination and educated guessing. The second clinical examination is performed within 24 h after admission and includes physical examination and educated guessing, biochemical analysis and CCUS assessments of heart, lungs, inferior vena cava (IVC) and kidney. This evaluation is repeated at days 3 and 5 after admission. CCUS images are validated by an independent expert, and all data is registered in an online secured database. Follow-up at 90 days includes registration of complications and survival status according to patient's medical charts and the municipal person registry. The primary focus of SICS-II is the association between venous congestion and organ dysfunction. The purpose of publishing this protocol is to provide details on the structure and methods of this ongoing prospective observational cohort study allowing answering multiple research questions. The design of the data collection of combined clinical examination and CCUS assessments in critically ill patients are explicated. The SICS-II is open for other centers to participate and is open for other research questions that can be answered with our data.

Clinical Examination for the Prediction of Mortality in the Critically Ill: The Simple Intensive Care Studies-I

“…Our clinical examination was limited to a single time point, which could explain why not all these common prognostic variables were also statistically significant in the SICS-I. Future research should study the variation of clinical examination and associated interventions over time to assess its prognostic value (40).…”

Different applications of the KDIGO criteria for AKI lead to different incidences in critically ill patients: a post hoc analysis from the prospective observational SICS-II study

“…The Simple Intensive Care Studies II (SICS-II) was a single-center, prospective observational study designed to evaluate the diagnostic and prognostic value of repeated clinical examination and ultrasonography in critically ill patients (NCT03577405) [18].…”

Should the ultrasound probe replace your stethoscope? A SICS-I sub-study comparing lung ultrasound and pulmonary auscultation in the critically ill

“…Auscultation was performed of the anterior and axillary lung fields in each hemithorax with the patient in a supine position. Subsequently, CCUS was performed following a predefined protocol using a phased array probe (M3S or M4S) set at a frequency of 3.6 MHz, a depth of 15 cm, and maximal image width (Vivid-S6, GE Healthcare, London, UK) [17]. LUS was performed using the Bedside Lung Ultrasound in Emergency (BLUE) protocol, assessing six scan sites per patient (superior, inferior, and lateral, bilateral) ( Fig.…”