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Continuous vs intermittent Non-Invasive blood pressure MONitoring in preventing postoperative organ failure (niMON): study protocol for an open-label, multicenter randomized trial

2024; BioMed Central; Volume: 4; Issue: 1 Linguagem: Inglês

10.1186/s44158-024-00142-w

2731-3786

Alberto Noto, Athanasios Chalkias, Fabiana Madotto, Lorenzo Ball, Elena Bignami, Maurizio Cecconi, Fabio Guarracino, Antonio Messina, Andrea Morelli, Pietro Princi, Filippo Sanfilippo, Sabino Scolletta, Luigi Tritapepe, Andrea Cortegiani, A. Mira, Agrippino Bellissima, Andrea Puppo, Alberto Nicolò Galvano, Alessandro Bristot, Alice Scannella, Alicia Ruiz-Escobar, Alicia Sanchez Duran, Andrea Micalef, Andrea Paolo Tramonte, Andreaserena Recchia, A. Zumpano, A. Ancona, Anna Cicalò, Anna Monardo, Anna Teresa Mazzeo, Antonio David, Antonio Gallina, Antonio Magrı̀, Antonio Pili, Barbara Bifarini, Barbara Franzoso, Beatrice Milan, Begona Ortega Eguiluz, Catalina Puigserver Martorell, Cecilia Novazzi, Celeste Cataldo, Chiara Fiandra, Chiara Merenda, Chiara Nicocia, Clara Bordes García, Claudia Crimi, Claudia Frigieri, Consuelo Brogno, Consuelo Coppola, Cristina Inoriza Nadal, D. Della Rocca, David Beniguria, David Pestaña, Davide Ottolina, Guido Di Gregorio, Diego Dominguez Flores, D Fiume, Domenico Russo, Eduardo Martin‐Sanz, Elena Albertí, Elena Conesa Lopez, Eleni Laou, Eliana Ximena Montsalve Ortiz, Emma Franceschi, Enrico Polati, Ernesto Trimarchi, Eros Gambaretti, Fabio Gori, F. Gentili, Federica Albanese, Federica Pennavaria, Filippo Benedetto, Flavia Falchetti, Florinda Messina, Gabriele Finco, Gabriele Selmo, Gabriele Recanelli, Gaetano Gallese, Giacomo Brondi, Giaime Putzu, Giovanna Semeraro, Giovanna Batista Pantas Braga, Giulia Pedini, Giulia Torregiani, Giulio Genoese, Giuseppe Calabrese, Giuseppe Stagliano, Giuseppe Servillo, G Zaffaroni, Grazia De Angelis, Graziano Leonardi, Guillermo Ferrer, Ines Verge Montano, Inmaculada Chinchurreta Barquero, Ivana Brunetti, Ivana Pezzoli, Jacopo Rama, Javier Ripollés–Melchor, Javier Silva Garcia, Jessica Giuseppina Maugeri, Jesus Garcia Arranz, Juan Vidaldiaz, Katia Audisio, Katia Donadello, Laura Camici, Laura Frigo, Leonardo Gottin, Luana Mollura, Luca Guzzetti, Lucia dei Rio Prieto, Lucia Falco, Lucia Tisner Yague, Luciana Raciti, Luigi Cardia, Luis Santè Serna, Manuela Nicastro, Marco Anderloni, Marco Covotta, Maria das Dôres Saraiva de Loreto, Maria de la Cruz Navas, Maria de los Angeles Chercoles Ruiz, Maria Guisasola Rabés, Mariachiara Ippolito, Marta Giordano, Martina Gioacchina Campione, Massimiliano Giardina, Massimiliano Paltenghi, Massimo Pisanti, Matteo Procopio, Maura Mancini, Melissa Carollo, Michela Massaro, Michele Chianchella, Nicola Logrieco, Nicolas Adam, Nicole Bardi, Orazio Mandraffino, Oscar Maraldo, Pamela Raggi, Paolo Attolini, Pasquale Vaira, Pasquale Buonanno, Patricia Galán Menéndez, Patrizia Morettoni, P. Papa, Paula Fernández-Valdés-Bango, P. Gaglioti, Pilar Cobeta, Placido Calì, Raffaele De Luca, R Russo, Giuseppe Rapisarda, Raquel Iniesta, Raquel Estevez Martinez, Riccardo Colombo, Rita Perna, Romolo Villani, Rosalía Pérez, Ruggero Vacirca, Salvatore Buscemi, Salvatore Napoli, Salvatore Sardo, S Taravella, Sara Accetta, Sebastiana Saglimbene, Selenia Venere Lanza, Serena Ricalzone, Silvia Nardi, Simone Binda, Simone Grasso, Tiziana Costagliola, Tiziana Palladino, Tommaso Fossali, Valentina Arcidiacono, Valentina Bellini, Valentina Ceccarelli, V. Girotto, Valeria Camemolla, Valeria Drago, Valerio Manfrellotti, Vincenzo Francesco Tripodi, Vito Delmonte, Walter Gallese, Zaira Simonelli,

Blood Pressure and Hypertension Studies

Abstract Background Blood pressure has become one of the most important vital signs to monitor in the perioperative setting. Recently, the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) recommended, with low level of evidence, continuous monitoring of blood pressure during the intraoperative period. Continuous monitoring allows for early detection of hypotension, which may potentially lead to a timely treatment. Whether the ability to detect more hypotension events by continuous noninvasive blood pressure (C-NiBP) monitoring can improve patient outcomes is still unclear. Here, we report the rationale, study design, and statistical analysis plan of the niMON trial, which aims to evaluate the effect of intraoperative C-NiBP compared with intermittent (I-NiBP) monitoring on postoperative myocardial and renal injury. Methods The niMon trial is an investigator-initiated, multicenter, international, open-label, parallel-group, randomized clinical trial. Eligible patients will be randomized in a 1:1 ratio to receive C-NiBP or I-NiBP as an intraoperative monitoring strategy. The proportion of patients who develop myocardial injury in the first postoperative week is the primary outcome; the secondary outcomes are the proportions of patients who develop postoperative AKI, in-hospital mortality rate, and 30 and 90 postoperative days events. A sample size of 1265 patients will provide a power of 80% to detect a 4% absolute reduction in the rate of the primary outcome. Conclusions The niMON data will provide evidence to guide the choice of the most appropriate intraoperative blood pressure monitoring strategy. Clinical trial registration Clinical Trial Registration: NCT05496322, registered on the 5 th of August 2023.