Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure (NiMon)

Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Hemodynamic Monitoring; Blood Pressure Determination
• Intervention / Treatment: Device: Continuous Non Invasive Blood Pressure Monitoring; Device: Intermittent Non Invasive Blood Pressure Monitoring

• Study Type: Interventional
• Enrollment (Actual): 1267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98100
    • A.O.U. G.Martino - University of Messina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adult (age ≥18 years) patients scheduled for elective non-cardiac surgery in participating centers
• Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies.

Exclusion Criteria:

• Missing of preoperative serum creatinine during 30 days prior surgery
• Preoperative dialysis
• Chronic kidney disease (eGFR < 60ml/min Cockcroft-Gault equation)
• Surgical procedure lasting less than 60 min
• Planned use of permissive hypotension
• Urological procedures (including nephrectomy and renal transplantation)
• Refusal to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cNIBP; Continuous non invasive blood pressure monitor (Volume clamp)	Device: Continuous Non Invasive Blood Pressure Monitoring; Continuous non-invasive arterial pressure monitoring
Active Comparator: iNIBP; Intermittent Non Invasive Blood Pressure (Brachial Cuff)	Device: Intermittent Non Invasive Blood Pressure Monitoring; Intermittent non-invasive arterial pressure monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative myocardial injury	The primary outcome will be the proportions of myocardial injury (Definitions: elevation of serum Troponin T (TnT) >= 30 ng/L in the first post-operative week)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Acute kidney injury	Proportions of postoperative AKI (Definition: increase in postoperative serum creatinine concentration during the first 7 postoperative days by more than 1.5-fold or greater than 0.3 mg/dl. Preoperative concentration was defined as the most recent recorded measurement within 30 days before the surgery)	1 week
Post operative death	Death during postoperative hospital stay	28 day after surgery
Events 30d post surgery	Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)	30 days after surgery
Events 90d post surgery	Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)	90 days after surgery

Collaborators and Investigators

• Sponsor: University of Messina
• Collaborators: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Publications and helpful links

General Publications

• Noto A, Chalkias A, Madotto F, Ball L, Bignami EG, Cecconi M, Guarracino F, Messina A, Morelli A, Princi P, Sanfilippo F, Scolletta S, Tritapepe L, Cortegiani A; SIAARTI Study Group. Continuous vs intermittent Non-Invasive blood pressure MONitoring in preventing postoperative organ failure (niMON): study protocol for an open-label, multicenter randomized trial. J Anesth Analg Crit Care. 2024 Feb 6;4(1):7. doi: 10.1186/s44158-024-00142-w.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Volume clamp; Continuous non invasive blood pressure monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: 16-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes