Clinical Trial Protocol
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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Effect of passive leg raising on the cross-sectional area of the right internal jugular vein in patients with obesity: a randomised controlled trial protocol.

BMJ Open 2024 May 7
BACKGROUND: Venous access in patients with obesity presents significant challenges. The success of central venous catheterisation largely depends on the cross-sectional area (CSA) of the internal jugular vein (IJV). While techniques like the Trendelenburg position have been traditionally used to increase IJV CSA, recent studies suggest its ineffectiveness in patients with obesity. Conversely, the potential of the effect of passive leg raising (PLR) has not been thoroughly investigated in this group of patients.

METHODS: This protocol outlines a planned randomised controlled trial to evaluate the effect of PLR on the CSA of the IJV in patients with obesity slated for central venous catheterisation. The protocol involves dividing 40 participants into two groups: one undergoing PLR and another serving as a control group without positional change. The protocol specifies measuring the CSA of the IJV via ultrasound as the primary outcome. Secondary outcomes will include the success rates of right IJV cannulation. The proposed statistical approach includes the use of t-tests to compare the changes in CSA between the two groups, with a significance threshold set at p<0.05.

ETHICS APPROVAL: This study has been approved by the Institutional Review Board of Shanghai Tongren Hospital. All the participants will provide informed consent prior to enrolment in the study. Regarding the dissemination of research findings, we plan to share the results through academic conferences and peer-reviewed publications. Additionally, we will communicate our findings to the public and professional communities, including patient advocacy groups.

TRIAL REGISTRATION NUMBER: ChiCTR: ChiCTR2400080513.

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