Evaluation of inhaled salbutamol effectiveness under supportive use of electrical impedance tomography in ventilated ICU patients: study protocol for a randomised controlled clinical trial

Abstract

IntroductionThe inhalative administration of drugs is a non-invasive application form that is regularly used in the treatment of ventilated patients in critical care setting. However, assessment of effectiveness or distribution of nebulised drugs is one of the lacking cornerstones of modern intensive care monitoring. Electrical impedance tomography (EIT) may provide a promising new monitoring and guiding tool for an adequate optimisation of mechanical ventilation in critically ill patients. EIT may assist in defining mechanical ventilation settings, assess distribution of tidal volume and evaluate associated pathologies at bedside. This study aims to elucidate the extent to which the effectiveness of inhaled salbutamol can be increased by the additional use of EIT for optimisation of respirator settings.Methods and analysisThis study is a randomised, open-label, superiority trial conducted on an intensive care unit of a German university hospital, comparing two groups of mechanically ventilated patients with an acute or chronic bronchial airway obstruction according to the effectiveness of inhaled salbutamol with (intervention) or without (control) additional use of EIT for optimising ventilator settings. The primary outcome is change in airway resistance 30 min after salbutamol inhalation.Ethics and disseminationThe study has received approval from the Ethics Committee of the Medical Faculty of Ruhr-University Bochum (17-6306). The results will be made available to critical care survivors, their caregivers, the funders, the critical care societies and other researchers by publication in a peer-reviewed journal.Trial registration numberDRKS00014706; Pre-results.