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

Postoperative Complications Clinical Trial

— NiMon  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496322
• Other study ID #: 16-22
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2023
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: University of Messina
• Contact: Alberto Noto
• Phone: +390902212450
• Email: alberto.noto[@]unime.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1265
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure Determination
• Hemodynamic Monitoring
• Postoperative Complications

Intervention

Device:
• Continuous Non Invasive Blood Pressure Monitoring
Continuous non-invasive arterial pressure monitoring
• Intermittent Non Invasive Blood Pressure Monitoring
Intermittent non-invasive arterial pressure monitoring

Locations

Country	Name	City	State
Italy	A.O.U. G.Martino - University of Messina	Messina

Sponsors (2)

Lead Sponsor	Collaborator
University of Messina	Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Post operative death	Death during postoperative hospital stay	28 day after surgery
Secondary	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
Secondary	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