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

University of Messina

Status: Enrolling

Conditions: Postoperative Complications; Blood Pressure Determination; Hemodynamic Monitoring

Treatments: Device: Intermittent Non Invasive Blood Pressure Monitoring; Device: Continuous Non Invasive Blood Pressure Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05496322

16-22

Details and patient eligibility

About

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

Enrollment: 1,265 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,265 participants in 2 patient groups

cNIBP

Experimental group

Description:

Continuous non invasive blood pressure monitor (Volume clamp)

Treatment:

Device: Continuous Non Invasive Blood Pressure Monitoring

iNIBP

Active Comparator group

Description:

Intermittent Non Invasive Blood Pressure (Brachial Cuff)

Treatment:

Device: Intermittent Non Invasive Blood Pressure Monitoring