A Study Protocol Exploring the Role of an Implantable Doppler Probe in Kidney Transplantation: A Feasibility Randomized Controlled Trial with an Embedded Qualitative Study.

Abstract

Vascular complications in kidney transplant surgery constitute one-third of early graft loss, which can be prevented by timely diagnosis of vascular compromise. A blood flow monitoring device may have a beneficial role in the early identification of graft hypoperfusion critical to reducing graft loss. This research protocol aims to evaluate the potential of an implantable Doppler probe as a blood flow monitoring device in kidney transplant recipients. The potential study will be a mixed methodology, 2-arm feasibility randomized controlled trial with an embedded qualitative study. For the trial, we will compare demographic characteristics and outcome measures of kidney transplant patients receiving implantable Doppler probe monitoring (intervention group, n = 30) with those having standard clinical care (control group). For the qualitative study, we will conduct semi-structured interviews with stakeholders (n = 12) recruited by purposive sampling to explore experiences of participants. All interviews will be audio recorded with verbatim transcription. Our results will use the summarized quantitative data and descriptive statistics to determine differences between the groups. We will use CONSORT guidelines to determine the suitability of the research processes, availability of research resources, and potential challenges faced during the feasibility randomized controlled trial. We will use thematic analysis and NVivo software to analyze the acceptability of the intervention in clinical practice. We will compile the results according to the consolidated criteria for reporting qualitative research checklist. The goal of this protocol is to determine the feasibility of an implantable Doppler probe monitoring device in kidney transplant recipients. The feasibility study will collect preliminary information, fill gaps in evidence, and test research processes for the pragmatic future randomized controlled trial. The template of this study is transferable to other transplant centers across the United Kingdom.