Mode of Ventilation During Critical Illness at Multiple Centers: a Pragmatic Clinical Trial

Vanderbilt University Medical Center, Nashville TN

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY Candidate: Kevin P. Seitz MD, MSc is an Instructor in Medicine and, by the time of this award, will be an Assistant Professor in the Division of Allergy, Pulmonary, and Critical Care Medicine at Vanderbilt. Dr. Seitz has a strong background in randomized trials among critically ill adults. His long-term plan is to be an independent physician-scientist and a leader in randomized trials of complex interventions in the ICU. During this career development award, he will lead a multicenter trial and develop the expertise in implementation science needed to optimize adherence during pragmatic trials of complex interventions in the ICU. Research Project: Every year, millions of adults in the United States receive invasive mechanical ventilation in ICUs, with a high risk of mortality. When using a mechanical ventilator, clinicians must choose from ventilator modes that control the tidal volume (volume control), the inspiratory pressure (pressure control), or a dual-control of volume and pressure using adaptive algorithms (adaptive pressure control). Data to inform the choice of mode are limited, and arbitrary variation in current practice may be harming patients. A multi-center trial is needed to understand the effects of ventilator mode on clinical outcomes. A pragmatic trial embedded in clinical care is appropriate for this goal. Ventilator mode use is a complex, multi-disciplinary, longitudinal intervention. Implementation science provides tools to identify and mitigate barriers to adherence for complex interventions in clinical care across varied settings that are well-suited to optimizing adherence to the assigned ventilator mode in a pragmatic trial. The Specific Aims of the proposed research are: Aim 1) Conduct the Mode Of ventilation During critical illnEss at Multiple centers (MODEM) trial, a 4,785-patient randomized cluster- crossover trial of critically ill adults testing the hypothesis that adaptive pressure control will increase the number of days alive and free of mechanical ventilation compared with volume control or pressure control. And Aim 2) Apply mixed methods to identify and intervene upon contextual factors that affect the adherence to the treatment group assignment in the MODEM trial, testing the hypothesis that this approach will result in at least 90% fidelity to assigned treatment in a pragmatic, multicenter trial of a complex intervention. Career Development: Dr. Seitz’s plan integrates coursework, experiential learning, and training with mentors to: 1) become expert in designing and leading comparative effectiveness trials embedded in clinical ICU care, 2) develop expertise in implementation science methods and proficiency in qualitative methods to improve the conduct of pragmatic trials, and 3) develop leadership skills to lead large, multi-center clinical trials. Environment: As a supportive and well-resourced institution with international leaders in clinical trials, critical care, human subjects protection, implementation science, bioinformatics, and biostatistics, Vanderbilt is the ideal environment to foster Dr. Seitz’s development into a national leader in trials of complex interventions.