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

Not Applicable

Recruiting

• Conditions: Postoperative Complications; Blood Pressure Determination; Hemodynamic Monitoring
• Interventions: Device: Intermittent Non Invasive Blood Pressure Monitoring; Device: Continuous Non Invasive Blood Pressure Monitoring

• Registration Number: NCT05496322
• Lead Sponsor: University of Messina

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-11
• Study Start: 2023-01-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1265

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iNIBP	Intermittent Non Invasive Blood Pressure Monitoring	Intermittent Non Invasive Blood Pressure (Brachial Cuff)
cNIBP	Continuous Non Invasive Blood Pressure Monitoring	Continuous non invasive blood pressure monitor (Volume clamp)

Primary Outcome Measures

Name	Time	Method
Post operative myocardial injury	1 week	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)

Secondary Outcome Measures

Name	Time	Method
Post operative death	28 day after surgery	Death during postoperative hospital stay
Events 30d post surgery	30 days after surgery	Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Events 90d post surgery	90 days after surgery	Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Post operative Acute kidney injury	1 week	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)

Trial Locations

Locations (1)

A.O.U. G.Martino - University of Messina; 🇮🇹 Messina, Italy