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Updated: Jul 10, 2026
10:38
Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
Feasibility, limits and problems of clinical studies in Intensive Care Unit
G Grasselli1, L Gattinoni, B Kavanagh
1Department of Perioperative Medicine and Intensive Care, San Gerardo Hospital, University Milano Bicocca, Milan, Italy.
Minerva Anestesiologica
|October 24, 2007
Summary
Generating high-quality evidence in critical care medicine is challenging due to complex patient conditions and trial design issues. This review discusses obstacles and opportunities for improving randomized controlled trials (RCTs) in intensive care units (ICUs).
Area of Science:
- Critical Care Medicine
- Clinical Research Methodology
Background:
- Limited evidence exists for managing common critical care conditions.
- Randomized controlled trials (RCTs) are crucial for evidence-based practice but face significant challenges in critical care.
Purpose of the Study:
- To review the intrinsic and structural problems complicating RCT design and conduct in critical care.
- To explore opportunities for advancing evidence generation in critical care medicine.
Main Methods:
- Discussion of challenges in critical care RCTs, including nosography, polypharmacy, and endpoint definition.
- Analysis of structural issues such as lack of ICU networks, funding, and integration of physiological objectives.
- Exploration of the relationship between critical care and Evidence-Based Medicine (EBM).
Main Results:
- RCTs in critical care are hindered by factors like unclear diagnoses, multiple concurrent treatments, and poorly defined outcomes.
- Difficulties include the absence of large ICU networks, challenges in protocol design, and limited non-profit funding.
- Meta-analyses may be less reliable due to the limited number and variable quality of critical care trials.
Conclusions:
- Addressing the identified challenges is essential for improving the quality and quantity of evidence in critical care.
- Strengthening critical care research requires overcoming methodological and structural barriers.
- Future directions involve enhancing the rigor of RCTs and leveraging EBM principles within critical care settings.
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