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Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial

Por: Messika · J. · Eloy · P. · Boulate · D. · Charvet · A. · Fessler · J. · Jougon · J. · Lacoste · P. · Mercier · O. · Portran · P. · Roze · H. · Sage · E. · Thes · J. · Tronc · F. · Vourc'h · M. · Montravers · P. · Castier · Y. · Mal · H. · Mordant · P. · Investigators from the ECMOToP Study
Introduction

Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.

Methods and analysis

We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.

Ethics and dissemination

The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.

Trial registration number

NCT05664204.

Telemedicine models of care: A retrospective review of telehealth in a Melbourne outpatient chronic wound service in 2021

Abstract

To review the application of telehealth guidelines developed by Bondini et al for clinicians to determine patient suitability for telehealth in an outpatient Chronic Wound Service, including the proportion of patients suitable for telehealth, type and mode of telehealth encounters. Retrospective, random convenience sample of patients attending the Chronic Wound Service in 2021. Fifty-six patients were included, most with leg/foot wounds (93%), median age 74 [54–84], 64% male. Four patients at admission and 19 patients at review met criteria for telehealth. Six percent of encounters were telehealth; phone-only (82%), unscheduled nursing reviews (77%) in patients with healing wounds. Thirty patients (54%) received at least one telehealth encounter. Telehealth occurred 35.6 days later in the admission than face-to-face encounters (p < 0.05, 95% CI 14.9–56.3). There was a significant relationship between patients receiving telehealth and meeting telehealth suitability criteria on reviews (X 2 (1) = 19.6*, p < 0.001). Eighteen percent of patients required wound-related hospitalisation during their outpatient admission. Telehealth guidelines identified patients suitable for telehealth, although the proportion of patients was small. Telehealth was mostly utilised for nurse-led telephone calls in patients with improving wounds. Future research into use of telephone review for clinical standards of wound care is warranted.

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