Prospective Validation of Intraoperative Blood Pressure Monitors
NCT Number: NCT06518980
Acronym: PROMISES
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia|Blood Pressure
Sponsor: Ciusss de L'Est de l'Île de Montréal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-10
Locations: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, Montréal-Est, Quebec, H1T2M4, Canada

Summary:
This observational study aims to identify the incidence and importance of discrepancies between measurements of intraoperative invasive and noninvasive blood pressure monitoring in patients undergoing non-cardiac surgeries under general anesthesia . The main questions it aims to answer are :

* The importance of the differences, in mmHg, between the non-invasive and invasive blood pressure measurements (NIBP-IBP) on systolic, diastolic and mean arterial pressure.
* Identify the predictive factors associated with these differences.

Primary Outcome Measures: Difference between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Describe the difference, in mm of Hg, between intraoperative monitoring of noninvasive and invasive blood (NIBP-IBP) on systolic, diastolic and mean arterial pressures, Time Frame: from arrival in preoperative unit patient's departure from PACU and/or removal of IBP device, expected duration approximately between 2 and 8 hours|Predictive factors associated with the between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurement differences, Identify predictive factors (such as patient, surgery, and anesthesia characteristics) statistically associated with the appearance of NIBP-IBP measurement differences, Time Frame: From patient file analysis at time of recruitment until patient's departure from PACU and/or removal of IBP device, expected duration approximately a year.
Secondary Outcome Measures: Comparison of preoperative NIBP and pre-induction NIBP, Compare preoperative non-invasive blood pressure (NIBP) measurements prior to the surgery and the average pre-induction NIBP recorded in the operating room, From installation of non-invasive blood pressure (NIBP) device in preop until installation of arterial line, pre-induction. Expected duration approximately between 1 and 2 hours.|Compare the discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements to the accuracy standards of the Association for the Advancement of Medical Instrumentation, Compare the NIBP-IBP discrepancy to the accuracy standards of the Association for the Advancement of Medical Instrumentation (AAMI): a maximal mean difference of 5 mm Hg and a standard deviation of 8 mm Hg., From installation of patient's arterial line until removal of patient's arterial line, expected duration approximately between 1 and 8 hours.|Impact of patient comorbidities (age, weight, height, BMI, heart condition, vascular condition) on occurrences of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Evaluate the impact of patient's characteristics and comorbidities collected via REDCap questionnaire (age, weight, height, BMI, heart condition, vascular condition) on the occurrence of NIBP-IBP discrepancies., From patient file analysis at time of recruitment until the end of statistical analysis. Expected duration: up to a year.|Statistical correlation between radial artery ultrasound measurements on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Evaluate the impact, via statistical analysis, of radial artery ultrasound characteristics (inter-intima diameter, velocity) on the occurrence of NIBP-IBP discrepancies., From measurement of patient's radial artery via ultrasonography before induction until the end of statistical analysis. Expected duration: up to a year.|Statistical correlation between administration of vasoactive drugs and fluids on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Evaluate the impact, via statistical analysis, of vasoactive drug administration and fluid (phenylephrine, ephedrine) administration on the occurrence of NIBP-IBP discrepancies, From administration of first fluid or vasoactive drug until patient's departure from PACU and/or removal of arterial line. Expected duration between 2 and 8 hours.|Statistical correlation between surgical characteristics (approach, duration, type of surgery, etc) on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Evaluate the impact, via statistical analysis, of surgical characteristics (approach, duration, type of surgery, etc) on the occurrence of NIBP-IBP measurement discrepancies., From patient file analysis at time of recruitment until the end of statistical analysis. Expected duration up to a year.|Statistical correlation between anesthesia condition on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Evaluate the impact of anesthesia condition (depth of anesthesia, nociception level) on the occurrence of NIBP-IBP discrepancies., From anesthesia induction until patient's departure from PACU and/or removal of arterial line, expected duration between 2 and 8 hours.|Describe the incidence of overdamping and underdamping upon installation of the arterial line, Describe the incidence of overdamping and underdamping upon installation of the arterial line, from installation of radial line until removal of arterial line. Expected duration between 5 and 15 minutes.|Describe the impact of overdamping and underdamping upon installation of the arterial line on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Describe the impact of overdamping and underdamping upon installation of the arterial line on the occurrence of NIBP-IBP discrepancies, Time Frame : from installation of radial line until removal of radial line. Expected duration between 1 and 8 hours.|Evaluate statistical correlation between anesthesiologist's confidence in the arterial line, and importance of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements, Evaluate the relation between the healthcare provider's confidence in the arterial line and the presence and importance of NIBP-IBP discrepancies. Confidence will be assessed at 30 minute intervals during the surgery by offering multiple choices for confidence ranking. Confidence scale will be as follows: 0= no trust in radial line, 1= weak trust in radial line, 2= moderate trust in radial line, 3=strong trust in radial line, 4= absolute trust in radial line, from installation of radial line until patient's departure from PACU and/or removal of arterial line. Expected duration between 1 andd 8 hours.