There is little consensus on the optimal set of outcomes to evaluate in research studies of neurocritical care patients undergoing mechanical ventilation, weaning, and extubation. The primary aim of this study is to develop a core outcome set (COS) for research studies of neurocritical care patients undergoing mechanical ventilation, weaning, and extubation. Our working definition of neurocritical care patients includes patients with either traumatic or non-traumatic acute brain injury. We aim to achieve international consensus using Delphi surveys and consensus meetings on outcomes included in the COS, their definitions, and when to measure them. The secondary aim is to reach consensus on a hierarchical composite endpoint for such studies. A composite endpoint includes two or more types of related clinical events and emphasizes a patient’s first event (often an outcome of lesser clinical importance). A hierarchical composite endpoint goes beyond this by ranking the included outcomes such that the emphasis is on the event of most clinical importance.
Our study differs from that of Blackwood et al (https://www.comet-initiative.org/Studies/Details/292) because although the outcomes included in their COS for the general critical care population are relevant for neurocritical patients, the appropriate metrics used to evaluate them may differ. Neurocritical care patients, in particular, experience longer duration of mechanical ventilation, higher extubation failure rates, and higher rates of tracheotomy compared with critically ill patients in general. This is reflective of additional challenges encountered in the process of liberation from mechanical ventilation in this subpopulation of critical care patients. Indeed, in addition to the standard assessment used to predict extubation success, additional or alternative factors may be considered when evaluating neurologic injury patients for extubation. For instance, the timing to define a successful extubation or to consider reintubation, or the metrics to evaluate the quality of health may differ in the neurocritical care population. There is a dearth of evidence for best clinical practices of mechanical ventilation, weaning, and extubation in this population. As more research in neurocritical care patients is needed, a COS specific to this population could guide primary and secondary outcomes of interest to ensure that evidence can be synthesized effectively.
To develop a COS for ventilation trials in neurocritical care patients
ContributorsRomain Pirracchio, Principal Investigator, Department of Anesthesia and Perioperative Care, University of California, San Francisco, USA
Raphaël Cinotti, Department of Anaesthesia and Critical Care, Hôpital Guillaume et René Laennec, University Hospital of Nantes, Saint-Herblain, France
Julian Bösel, Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany
Chiara Robba, Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy
Robert Stevens, Department of Anesthesia, Johns Hopkins, USA
Disease Category: Neurology
Disease Name: Brain injury (traumatic), Traumatic and non-traumatic acute brain injury patients
Age Range: 18
Sex: Either
Nature of Intervention: Mechanical ventilation
- Clinical experts
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Literature review
- Survey
- Systematic review
This study will follow the Core Outcome Set-STAndards for Development (COS-STAD) for the design of COS studies. We developed and structured the protocol in accordance with the Core Outcome Set-STAndardised Protocol Items (COS-STAP).
The study will include a broadly representative, international panel of stakeholders and involve four stages: 1) a literature review to generate an initial list of outcomes, 2) an investigator meeting to review the outcomes for inclusion in the Delphi surveys, 3) four rounds of online Delphi consensus-building surveys, and 4) online consensus meetings to finalize the COS and hierarchical composite endpoint.