Prospective Clinical Evaluation of New ECCO2R Technology With ULPV in Moderate ARDS Patients

Monday, March 23, 2026

10:15 AM - 11:15 AM Central Time

Location: Connections Central - RST 03

Joerg S. Kurz, n/a (he/him/his)

Bayern, DEU

Disclosure(s): Vantive Healthcare LLC: Employee (any industry) (Ongoing)
AC

Alain Combes, n/a

Director of ICU
La Pitié-Salpêtrière University Hospital, Medical Intensive Care Unit, APHP, France, Ile-de-France, France

Disclosure information not submitted.
SJ

Samir Jaber, N/A

Professor - Head of Anesthesia and Critical care at Saint Eloi Hopsital
University of Montpellier, Languedoc-Roussillon, France

Disclosure information not submitted.
BL

Bruno Levy, n/a

Professor and Director of Deparment of Anesthesia and Intensive Care Medicine
University of Nancy, Lorraine, France

Disclosure information not submitted.
RT

Romain Tapponnier, N/A

Dr - Senior Physician
University of Besancon, Franche-Comte, France

Disclosure information not submitted.
JG

Jacques Goldstein, n/a

Professor & Consultant
Cardiogold, Brabant Wallon, Belgium

Disclosure information not submitted.
KH

Kai Harenski, N/A

Senior Medical DIrector
Vantive Health, Germany

Disclosure information not submitted.
WM

William Montgomery, n/a

Senior Clinical DIrector
Vantive Healthcare LLC, Illinois

Disclosure information not submitted.

Introduction: This multicenter, prospective, study in France evaluated the safety and effectiveness of PRISMALUNG+ (PL+), a new ECCO2R membrane lung designed for use alone or with continuous renal replacement therapy (CRRT & PL+), as an adjunct to mechanical ventilation for treating hypercapnic acidosis during ultra-lung protective ventilation (ULPV) in moderate acute respiratory distress syndrome (ARDS) patients.

Methods: From April 2021 to December 2023, 58 ARDS patients across 10 centers received heparin and had stepwise tidal volume (VT) reduction from 6 mL/kg to 4 mL/kg. Sweep gas (100% O2 at 10L/min) was initiated when PaCO2 >50 mmHg. Outcomes were measured at 8 and 24 hours; safety was monitored until discharge or day 28.

Results: Data are presented as median [IQR], unless stated otherwise. Among 58 (PL+=42 patients; CRRT & PL+=16 patients), mainly male patients (74.1%), aged 63.5 [55.0-69.0] years, baseline SAPS II was 45.0 [39.0-63.0], SOFA was 8.5 [6.0-11.0], and PaO2/FiO2 was 163.3 [135.0-204.7] mmHg. Before ECCO2R, peak hypercapnia and respiratory acidosis reached PaCO2 of 53.0 [50.0-55.0] mmHg and a pH of 7.30 [7.24-7.36]. ECCO2R lasted for 43.1 [24.1-69.3] hours at 350 [300-400] mL/min flow. VT fell from 6.0 [6.0-6.1] to 4.0 [4.0-4.30] (p < 0.0001), and driving pressure improved from 12.0 [10.0-16.0] cmH2O to 10.0 [8.0-13.0] cmH2O (p=0.0001) after 24 hours. Ventilatory ratio decreased from 1.7 [1.5-2.1] at baseline to 1.3 [1.0-1.6] after 24 hours (p < 0.0001). Respiratory acidosis resolved with treatment, as evidenced by normalization of pH and reduction of PaCO2 within 24 hours. Specifically, baseline pH was 7.38 [7.31-7.43] and remaining unchanged at 24 hours (7.38 [7.34-7.42]; p = 0.2704) while baseline PaCO2 was 42.0 [39.0-46.0] mmHg compared to 45.2 [41.0-50.1] mmHg at 24 hours (p=0.0025). CO2 clearance after 8h was 82.3 mL/min (PL+) and 77.3 mL/min (CRRT & PL+). The mean (SD) lifetime of the extracorporeal circuit was 27.5 (±24.9) hours for PL+ and 46.8 (±29.0) hours for CRRT & PL+. No major bleeding events occurred during ECCO2R; however, 2 patients experienced minor ischemic strokes post-treatment, unrelated to the device.

Conclusions: PL+ effectively and safely clears CO2 and enables ULPV without causing hypercapnic acidosis.