Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure (NiMon)
Primary Purpose
Blood Pressure Determination, Hemodynamic Monitoring, Postoperative Complications
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Continuous Non Invasive Blood Pressure Monitoring
Intermittent Non Invasive Blood Pressure Monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Blood Pressure Determination focused on measuring Volume clamp, Continuous non invasive blood pressure monitoring
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
Sites / Locations
- A.O.U. G.Martino - University of MessinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cNIBP
iNIBP
Arm Description
Continuous non invasive blood pressure monitor (Volume clamp)
Intermittent Non Invasive Blood Pressure (Brachial Cuff)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Post operative death
Death during postoperative hospital stay
Events 30d post surgery
Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Events 90d post surgery
Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Full Information
NCT ID
NCT05496322
First Posted
August 5, 2022
Last Updated
January 26, 2023
Sponsor
University of Messina
Collaborators
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
1. Study Identification
Unique Protocol Identification Number
NCT05496322
Brief Title
Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
Acronym
NiMon
Official Title
Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
Collaborators
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure Determination, Hemodynamic Monitoring, Postoperative Complications
Keywords
Volume clamp, Continuous non invasive blood pressure monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1265 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cNIBP
Arm Type
Experimental
Arm Description
Continuous non invasive blood pressure monitor (Volume clamp)
Arm Title
iNIBP
Arm Type
Active Comparator
Arm Description
Intermittent Non Invasive Blood Pressure (Brachial Cuff)
Intervention Type
Device
Intervention Name(s)
Continuous Non Invasive Blood Pressure Monitoring
Intervention Description
Continuous non-invasive arterial pressure monitoring
Intervention Type
Device
Intervention Name(s)
Intermittent Non Invasive Blood Pressure Monitoring
Intervention Description
Intermittent non-invasive arterial pressure monitoring
Primary Outcome Measure Information:
Title
Post operative myocardial injury
Description
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)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Post operative Acute kidney injury
Description
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)
Time Frame
1 week
Title
Post operative death
Description
Death during postoperative hospital stay
Time Frame
28 day after surgery
Title
Events 30d post surgery
Description
Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Time Frame
30 days after surgery
Title
Events 90d post surgery
Description
Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death)
Time Frame
90 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Noto
Phone
+390902212450
Email
alberto.noto@unime.it
Facility Information:
Facility Name
A.O.U. G.Martino - University of Messina
City
Messina
ZIP/Postal Code
98100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Noto
Email
dralbert@unime.it
12. IPD Sharing Statement
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Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
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