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