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Impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients: the VA

Por: Demaure · N. · Le Cunff · J. · Duchene · M. · Rozec · B. · Espitalier · F. · Cabon · J.-M. · Oilleau · J.-F. · Guerci · P. · Labaste · F. · Abou-Arab · O. · Guinot · P.-G. · Duval · P. · Besnier · E. · Flecher · E. · Leroyer · I. · Morcet · J. · Fougerou-Leurent · C. · Mansour · A. · Nesse
Introduction

Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.

Methods/analysis

In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.

Ethics and dissemination

The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.

Trial registration number

ClinicalTrials.gov NCT04408495.

Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial--the EASY-CS study

Por: Beyls · C. · Mollet · N. · Gibert · L. · Huette · P. · Khamari · M. · Meynier · J. · Abou-Arab · O. · Mahjoub · Y.
Introduction

Fluid overload (FO) is a common complication following cardiac surgery with cardiopulmonary bypass (CPB) and is associated with increased morbidity and mortality. Loop diuretics, particularly furosemide, are widely used to promote sodium and water excretion, but their postoperative use remains largely empirical. International guidelines recommend early assessment of diuretic response using spot urinary sodium concentration, traditionally measured by automated laboratory analysers. Recent advances now enable bedside measurement of natriuresis using point-of-care (POC) urinary sodium sensors. This trial aims to determine whether real-time bedside natriuresis monitoring using a POC device can guide safer and more effective diuretic strategies in the postoperative management of FO.

Materials and methods

The EASY-CS trial is a prospective, single-centre, open-label, randomised controlled trial designed to evaluate whether a natriuresis-guided furosemide titration protocol improves diuresis within 48 hours following cardiac surgery with CPB. A total of 102 adult patients undergoing elective cardiac surgery with CPB and requiring postoperative intravenous (IV) furosemide for FO will be randomised in a 1:1 ratio to either standard care (n=51; furosemide titration based on clinical judgement) or a natriuresis-guided arm (n=51), in which furosemide dosing is adjusted according to urinary sodium concentration. All patients will receive an initial 20 mg dose of IV furosemide. In the intervention group, urinary sodium will be measured every 6 hours using a POC sodium sensor (LAQUAtwin Na+ metre, Horiba, Japan). If the spot urinary sodium is

Secondary outcomes include urinary sodium concentration and urine output at 24 hours, natriuresis at 48 hours, and the venous excess ultrasound score at 48 hours, as determined by transthoracic echocardiography. The study will also assess total loop diuretic dose administered, cumulative fluid balance over 48 hours and the incidence of postoperative complications at day 30, including cardiovascular, renal, respiratory and gastrointestinal events. Safety endpoints include the presence of hypotension, hypokalaemia or acute kidney injury before each diuretic administration. Randomisation will be stratified by EuroSCORE II (

Ethics and dissemination

Ethical approval has been obtained from the Institutional Review Board (IRB) of Amiens University hospital (IRB-ID: 2025-A00925-44). The study’s results will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Trial registration number

ClinicalTrials.gov Identifier: NCT07077772.

Effect of a virtual reality program on patient comfort in the surgical intensive care unit of a French university hospital: study protocol for a monocentric, prospective, superiority, randomised controlled trial-ZION study

Por: Huette · P. · Malaquin · S. · Lefebvre · T. · Devos · C. · Ibrahima · A. · Daumin · C. · Coupez · A. · Josse · E. · Besserve · P. · Haye · G. · Bayart · G. · Guilbart · M. · Gibert · L. · Beyls · C. · Dupont · H. · Meynier · J. · Diouf · M. · Mahjoub · Y. · Abou-Arab · O.
Introduction

Admission to a surgical intensive care unit (ICU) following major surgery is associated with a number of discomforts, not only related to the disease itself but also to the care provided or the ICU environment itself (lights, sounds, pain, sleep deprivation, thirst, etc). This discomfort is real and can be associated with psychological consequences. We hypothesised that the use of immersive virtual reality (IVR) with HypnoVR is feasible and can help reduce discomfort in intensive care.

Methods and analysis

The ZION trial is a prospective, monocentric trial randomising 194 patients admitted to a surgical ICU after a major surgery. The inclusion criterion is patients admitted to a surgical ICU for at least 48 hours following major surgery (cardiac, thoracic or major abdominal surgery). Patients will be allocated to the intervention group (n=97) or the control group (n=97). In the intervention group, patients will receive IVR using HypnoVR two times a day during the ICU stay (2–5 days). In the control group, postoperative care will be conducted according to standard care without IVR. The primary endpoint will be the 18-item IPREA (Inconforts des Patients de REAnimation) questionnaire on the day of ICU discharge. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnoea, thirst and sleep deprivation); the 18-Item IPREA Questionnaire assessed daily from randomisation to the V1 follow-up visit (ICU discharge); incidence of delirium; cumulative morphine consumption at ICU discharge; length of ICU stay and anxiety or depression at 1 month after discharge from intensive care and patient experience of device use.

Ethics and dissemination

Ethical approval was obtained from the institutional review board of the University Hospital of Amiens (Registration number ID: 2024-A01528-39) in January 2025.

Trial registration number

NCT06830369.

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