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

NCT05496322 | Completed DMC FDA Device

• 1 other identifier: 16-22
• Study Type: interventional
• Target: 1,267
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Pressure Determination; Hemodynamic Monitoring; Postoperative Complications

Keywords

Volume clamp; Continuous non invasive blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Post operative Acute kidney injury

  1 week

• Post operative death

  28 day after surgery

• Events 30d post surgery

  30 days after surgery

• Events 90d post surgery

  90 days after surgery

Study Arms (2)

cNIBP

EXPERIMENTAL

Continuous non invasive blood pressure monitor (Volume clamp)

Device: Continuous Non Invasive Blood Pressure Monitoring

iNIBP

ACTIVE COMPARATOR

Intermittent Non Invasive Blood Pressure (Brachial Cuff)

Device: Intermittent Non Invasive Blood Pressure Monitoring

Interventions

Continuous Non Invasive Blood Pressure Monitoring DEVICE

Continuous non-invasive arterial pressure monitoring

cNIBP

Intermittent Non Invasive Blood Pressure Monitoring DEVICE

Intermittent non-invasive arterial pressure monitoring

iNIBP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Messina: lead
• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: collaborator

Study Sites (1)

A.O.U. G.Martino - University of Messina

Messina, 98100, Italy

Location

Related Publications (1)

• 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.

  PMID: 38321507 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 11, 2022
• Study Start: January 26, 2023
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

IT (1)