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Clinical Trials/NCT05496322
NCT05496322
Completed
Not Applicable

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

University of Messina1 site in 1 country1,267 target enrollmentJanuary 26, 2023

Overview

Phase
Not Applicable
Intervention
Continuous Non Invasive Blood Pressure Monitoring
Conditions
Blood Pressure Determination
Sponsor
University of Messina
Enrollment
1267
Locations
1
Primary Endpoint
Post operative myocardial injury
Status
Completed
Last Updated
last month

Overview

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

Registry
clinicaltrials.gov
Start Date
January 26, 2023
End Date
July 1, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alberto Noto

Prof.

University of Messina

Eligibility Criteria

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

Arms & Interventions

cNIBP

Continuous non invasive blood pressure monitor (Volume clamp)

Intervention: Continuous Non Invasive Blood Pressure Monitoring

iNIBP

Intermittent Non Invasive Blood Pressure (Brachial Cuff)

Intervention: Intermittent Non Invasive Blood Pressure Monitoring

Outcomes

Primary Outcomes

Post operative myocardial injury

Time Frame: 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 Outcomes

  • Post operative death(28 day after surgery)
  • Events 30d post surgery(30 days after surgery)
  • Events 90d post surgery(90 days after surgery)
  • Post operative Acute kidney injury(1 week)

Study Sites (1)

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