Prospective Validation of Intraoperative Blood Pressure Monitors
- Conditions
- AnesthesiaBlood Pressure
- Registration Number
- NCT06518980
- Lead Sponsor
- Ciusss de L'Est de l'Île de Montréal
- Brief 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.
- Detailed Description
The monitoring of arterial blood pressure, invasively or noninvasively, is a requirement for perioperative hemodynamic and anesthesia management to optimize the administration of fluids and vasopressors. Numerous trials have highlighted the consequences of intraoperative blood pressure variability regarding the risk of serious complications and postoperative mortality associated with organ ischemia, and bleeding. Precisely, intraoperative hypotension (MAP \<65 mm Hg) has been associated with cardiac complications as well as acute kidney injury. While no optimal intraoperative blood pressure targets has been established to minimize perioperative complications, a recent comprehensive literature review established recommended mean arterial pressure (MAP), and blood pressure (BP) targets within 100% to 120% of BP baseline with MAP ≥60 mm Hg if the patient presented low baseline (systolic BP \<90 mm Hg or diastolic BP \<50 mm Hg), and MAP within 90% to 110% BP baseline and ≈65 to 95 mm Hg for normal baseline (systolic BP 90-129 mm Hg and diastolic BP 50-79 mm Hg) patients.
Invasive blood pressure monitoring by arterial catheterization is the gold standard in intraoperative hemodynamic management. While providing continuous blood pressure readings allowing for dynamic and constant monitoring, clinically relevant transducer inaccuracies have been documented, present in up to 30% of patients. Within patients of the same study, comparison of invasive and noninvasive blood pressure demonstrated considerable overestimation of systolic blood pressure and underestimation of diastolic blood pressure.
Oscillometric blood pressure monitoring is noninvasive, quick, and effortless.Despite its convenience, the oscillometric monitoring of blood pressure does not allow for continuous blood pressure measurement, possibly delaying or missing the recognition of hypotensive episodes. Moreover, oscillometric devices can tend to inaccurately measure blood pressure in comparison to invasive monitoring methods. In intraoperative and critical care settings, studies have shown oscillometric devices' tendencies to overestimate low blood pressure, failing to accurately detect hypotensive episodes, thus demonstrating the superiority of invasive monitoring methods.
The discrepancies between invasive and noninvasive methods of blood pressure monitoring have been described in prior studies. It has been determined that noninvasive blood pressure tended to be greater than invasive blood pressure in 56.1% of systolic measurements, and 67.3% of diastolic measurements for the same patient. Furthermore, noninvasive blood pressure readings tend to overestimate mean arterial pressure for low blood pressure values, and to underestimate mean arterial pressure for high blood pressure values.
Considering the consequences associated with even short intraoperative hypotensive episodes, the discrepancies between noninvasive and invasive blood pressure monitoring are not negligible. Currently, little is known about the relation between these discrepancies and contextual elements linked to the patient or the surgery.
Therefore, this prospective observational trial aims to identify the incidence of gradients between intraoperative noninvasive and invasive blood pressure monitoring and extract key relationships between the occurrence of these gradients and the patient's comorbidity profile, the monitor's parameters and artifacts, and the perioperative chronology.
Study duration: 12 months
Study Center: Maisonneuve-Rosemont Hospital, Integrated University Health and Social Services Centre (CIUSSS) de l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montreal, Quebec, Canada.
Adverse Events: there is very little risk involved with participation in this study, side effects that may be associated with the use of intra-radial canula for invasive blood pressure measurement.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Fully consented, adult patients above 18 years old;
- Undergoing surgery of duration time expected at least 60 minutes using general anesthesia;
- Supine positioning during the surgery;
- Surgery requiring an arterial line;
- Both arms available for instrumentation during the surgery.
- Atrial fibrillation, multifocal atrial tachycardia, or any other irregular hear rythm;
- Gradient of mean arterial pressure between the two arms greater than 5 mm Hg, as measured during the recruitment process.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictive factors associated with the between non-invasive blood pressure (NIBP) and invasive blood pressure (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. Identify predictive factors (such as patient, surgery, and anesthesia characteristics) statistically associated with the appearance of NIBP-IBP measurement differences
Difference between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements 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 Describe the difference, in mm of Hg, between intraoperative monitoring of noninvasive and invasive blood (NIBP-IBP) on systolic, diastolic and mean arterial pressures
- Secondary Outcome Measures
Name Time Method 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 From patient file analysis at time of recruitment until the end of statistical analysis. Expected duration: up to a year. 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.
Comparison of preoperative NIBP and pre-induction NIBP 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 preoperative non-invasive blood pressure (NIBP) measurements prior to the surgery and the average pre-induction NIBP recorded in the operating room
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 From installation of patient's arterial line until removal of patient's arterial line, expected duration approximately between 1 and 8 hours. 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.
Statistical correlation between anesthesia condition on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements From anesthesia induction until patient's departure from PACU and/or removal of arterial line, expected duration between 2 and 8 hours. Evaluate the impact of anesthesia condition (depth of anesthesia, nociception level) on the occurrence of NIBP-IBP discrepancies.
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 incidence of overdamping and underdamping upon installation of the arterial line
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 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. Evaluate the impact, via statistical analysis, of vasoactive drug administration and fluid (phenylephrine, ephedrine) administration on the occurrence of NIBP-IBP discrepancies
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 From patient file analysis at time of recruitment until the end of statistical analysis. Expected duration up to a year. Evaluate the impact, via statistical analysis, of surgical characteristics (approach, duration, type of surgery, etc) on the occurrence of NIBP-IBP measurement discrepancies.
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 Time Frame : from installation of radial line until removal of radial line. Expected duration between 1 and 8 hours. Describe the impact of overdamping and underdamping upon installation of the arterial line on the occurrence of NIBP-IBP discrepancies
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 from installation of radial line until patient's departure from PACU and/or removal of arterial line. Expected duration between 1 andd 8 hours. 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
Statistical correlation between radial artery ultrasound measurements on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements From measurement of patient's radial artery via ultrasonography before induction until the end of statistical analysis. Expected duration: up to a year. Evaluate the impact, via statistical analysis, of radial artery ultrasound characteristics (inter-intima diameter, velocity) on the occurrence of NIBP-IBP discrepancies.
Trial Locations
- Locations (1)
Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
🇨🇦Montréal-Est, Quebec, Canada