Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Feb 6;4(1):7.
doi: 10.1186/s44158-024-00142-w.

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

Alberto Noto  1 , Athanasios Chalkias  2   3 , Fabiana Madotto  4 , Lorenzo Ball  5   6 , Elena Giovanna Bignami  7 , Maurizio Cecconi  8   9 , Fabio Guarracino  10 , Antonio Messina  8   9 , Andrea Morelli  11 , Pietro Princi  12 , Filippo Sanfilippo  13 , Sabino Scolletta  14 , Luigi Tritapepe  15 , Andrea Cortegiani  16   17 ; SIAARTI Study Group
Collaborators, Affiliations

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

Alberto Noto et al. J Anesth Analg Crit Care. .

Erratum in

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 5th of August 2023.

Keywords: Blood pressure; Hemodynamic monitoring; Intraoperative monitoring; Postoperative complications; Volume clamp.

PubMed Disclaimer

Conflict of interest statement

MC is a consultant for Edwards Lifesciences (Directed Systems Consultancy); FG received lecture fees from Abbott, AOP Orphan, Edwards Lifesciences, Masimo, Orion, and Viatris; AM received travel expenses and registration for meetings, congresses, courses, and lecture fees from Vygon, Phlips, Edwards; SS is a consultant for Vygon.

The other authors declare no competing interests.

References

    1. Li G, Warner M, Lang BH, Huang L, Sun LS. Epidemiology of anesthesia-related mortality in the United States, 1999–2005. Anesthesiology. 2009;110:759–765. doi: 10.1097/ALN.0b013e31819b5bdc. - DOI - PMC - PubMed
    1. Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, et al. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012;380:1059–1065. doi: 10.1016/S0140-6736(12)61148-9. - DOI - PMC - PubMed
    1. Ahuja S, Mascha EJ, Yang D, Maheshwari K, Cohen B, Khanna AK, et al. Associations of intraoperative radial arterial systolic, diastolic, mean, and pulse pressures with myocardial and acute kidney injury after noncardiac surgery. Anesthesiology. 2020;132:291–306. doi: 10.1097/ALN.0000000000003048. - DOI - PubMed
    1. Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vásquez SM, et al. Period-dependent associations between hypotension during and for four days after noncardiac surgery and a composite of myocardial infarction and death. Anesthesiology. 2018;128:317–327. doi: 10.1097/ALN.0000000000001985. - DOI - PubMed
    1. van Waes JAR, van Klei WA, Wijeysundera DN, van Wolfswinkel L, Lindsay TF, Beattie WS. Association between intraoperative hypotension and myocardial injury after vascular surgery. Anesthesiology. 2016;124:35–44. doi: 10.1097/ALN.0000000000000922. - DOI - PubMed

Associated data

LinkOut - more resources