Continuous vs intermittent Non-Invasive blood pressure MONitoring in preventing postoperative organ failure (niMON): study protocol for an open-label, multicenter randomized trial
Authors: Noto Alberto , Chalkias Athanasios , Madotto Fabiana , Ball Lorenzo , Bignami Elena Giovanna , Cecconi Maurizio , Guarracino Fabio , Messina Antonio , Morelli Andrea , Princi Pietro , Sanfilippo Filippo , Scolletta Sabino , Tritapepe Luigi , Cortegiani Andrea ,   SIAARTI Study Group, Mira Adrian , Bellissima Agrippino , Puppo Andrea , Galvano Alberto , Bristot Alessandro , Scannella Alice , Ruiz-Escobar Alicia , Duran Alicia Sanchez , Micalef Andrea , Tramonte Andrea Paolo , Recchia Andreaserena , Zumpano Angela , Ancona Angelica , Cicalò Anna , Monardo Anna , Mazzeo Annateresa , David Antonio , Gallina Antonio , Magri Antonio , Pili Antonio , Bifarini Barbara , Franzoso Barbara , Milan Beatrice , Eguiluz Begona Ortega , Martorell Catalina Puigserver , Novazzi Cecilia , Cataldo Celeste , Fiandra Chiara , Merenda Chiara , Nicocia Chiara , García Clara Bordes , Crimi Claudia , Frigieri Claudia , Brogno Consuelo , Coppola Consuelo , Nadal Cristina Inoriza , Rocca Dario , Beniguria David , Pestaña David , Ottolina Davide , Di Gregorio Guido , Flores Diego Dominguez , Fiume Diego , Russo Domenico , Martin Eduardo , Alberti Elena , Lopez Elena Conesa , Laou Eleni , Ortiz Eliana Ximena Montsalve , Franceschi Emma , Polati Enrico , Trimarchi Ernesto , Gambaretti Eros , Gori Fabio , Gentili Fabrizia , Albanese Federica , Pennavaria Federica , Benedetto Filippo , Falchetti Flavia , Messina Florinda , Finco Gabriele , Selmo Gabriele , Recanelli Gabriele , Gallese Gaetano , Brondi Giacomo , Putzu Giaime , Semeraro Giovanna , Braga Giovanna , Pedini Giulia , Torregiani Giulia , Genoese Giulio , Calabrese Giuseppe , Stagliano Giuseppe , Servillo Giuseppe , Zaffaroni Gloria , De Angelis Grazia , Leonardi Graziano , Ferrer Guillermo , Montano Ines Verge , Barquero Inmaculada Chinchurreta , Brunetti Ivana , Pezzoli Ivana , Rama Jacopo , Melchor Javier Ripollés , Garcia Javier Silva , Maugeri Jessica Giuseppina , Arranz Jesus Garcia , Vidaldiaz Juan , Audisio Katia , Donadello Katia , Camici Laura , Frigo Laura , Gottin Leonardo , Mollura Luana , Guzzetti Luca , Prieto Lucia dei Rio , Di Falco Lucia , Yague Lucia Tisner , Raciti Luciana , Cardia Luigi , Serna Luis Santè , Nicastro Manuela , Anderloni Marco , Covotta Marco , Loreto Maria , de la Cruz Navas Maria , de los Angeles Chercoles Ruiz Maria , Rabés Maria Guisasola , Ippolito Mariachiara , Giordano Marta , Campione Martina , Giardina Massimiliano , Paltenghi Massimiliano , Pisanti Massimo , Procopio Matteo , Mancini Maura , Carollo Melissa , Massaro Michela , Chianchella Michele , Logrieco Nicola , Adam Nicolas , Bardi Nicole , Mandraffino Orazio , Maraldo Oscar , Raggi Pamela , Attolini Paolo , Vaira Pasquale , Buonanno Pasquale , Menéndez Patricia Galán , Morettoni Patrizia , Papa Patrizio , Fernández-Valdes-Bango Paula , Gaglioti Pier Paolo , cobeta Pilar , Calì Placido , De Luca Raffaele , Russo Raffaele , Rapisarda Giuseppe , Del Reino Iniesta Raquel , Martinez Raquel Estevez , Colombo Riccardo , Perna Rita , Villani Romolo , Perez Rosalia Navarro , Vacirca Ruggero , Buscemi Salvatore , Napoli Salvatore , Sardo Salvatore , Taravella Salvatrice , Accetta Sara , Saglimbene Sebastiana , Lanza Selenia Venere , Ricalzone Serena , Nardi Silvia , Binda Simone , Grasso Simone , Costagliola Tiziana , Palladino Tiziana , Fossali Tommaso , Arcidiacono Valentina , Bellini Valentina , Ceccarelli Valentina , Girotto Valentina , Camemolla Valeria , Drago Valeria , Manfrellotti Valerio , Tripodi Vincenzo Francesco , Delmonte Vito , Gallese Walter , Simonelli Zaira 
Published: February 2024

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 5th of August 2023.