Clinical study of area-decreasing technique and conventional post-closure technique for V-A ECMO weaning application: study protocol of a randomised controlled trial.

INTRODUCTION

Two techniques are commonly used for the femoral artery puncture closure during decannulation in venoarterial extracorporeal membrane oxygenation (V-A ECMO): the conventional post-closure technique and the small-sheath technique, also referred to as the area-decreasing technique. To date, no standardised protocol has been established for femoral artery closure following V-A ECMO decannulation. This study aimed to determine whether the area-decreasing technique results in reduced arterial blood loss compared with the conventional post-closure technique.

METHODS AND ANALYSIS: This is a prospective, single-centre, open-label, randomised controlled trial. We plan to recruit 110 participants (aged ≥18 years) from the ECMO Centre of the First Hospital of Lanzhou University, China, all of whom will undergo femoral artery closure using the ProGlide system following V-A ECMO support. Participants will be randomly assigned in a 1:1 ratio to undergo either the conventional post-closure technique or the area-decreasing technique. The primary endpoint is arterial blood loss. Secondary endpoints include immediate technical success rate, arterial suture time, in-hospital mortality, in-hospital lower limb-related complications after decannulation, 30-day mortality and 30-day lower limb-related complications. Safety endpoints include the incidence of complications requiring surgical or interventional management and the rate of amputation.

ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the First Hospital of Lanzhou University (Approval ID: LDYYLL2024-36). Written informed consent was obtained from all participants before data collection. Study findings will be published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR2400084539.