Prospective Validation of Intraoperative Blood Pressure Monitors (PROMISES)

Prospective Validation of Intraoperative Blood Pressure Monitors: the Influence of Site and Execution Strategy. The PROMISES Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure; Anesthesia

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Nadia Godin; Phone Number: 3193 514-252-3400; Email: ngodin.hmr@ssss.gouv.qc.ca
• Study Contact Backup: Name: Pascal Laferrière-Langlois; Phone Number: +1-819-432-5847; Email: pascal.laferriere-langlois@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal-Est, Quebec, Canada, H1T2M4
      • Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
      • Contact: Pascal Laferrière-Langlois, MD, FRQS; Phone Number: +1-819-432-5847; Email: pascal.laferriere-langlois@umontreal.ca
      • Principal Investigator: Pascal Laferrière-Langlois, MD, FRQS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing non-cardiac elective surgery expected to last at least 60 minutes, under general anesthesia, and to require an arterial line.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Ciusss de L'Est de l'Île de Montréal
• Investigators: Principal Investigator: Pascal Laferrière-Langlois, Ciusss de L'Est de l'Île de Montréal

Publications and helpful links

General Publications

• Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
• Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
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• Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
• van Waes JA, van Klei WA, Wijeysundera DN, van Wolfswinkel L, Lindsay TF, Beattie WS. Association between Intraoperative Hypotension and Myocardial Injury after Vascular Surgery. Anesthesiology. 2016 Jan;124(1):35-44. doi: 10.1097/ALN.0000000000000922.
• Mascha EJ, Yang D, Weiss S, Sessler DI. Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology. 2015 Jul;123(1):79-91. doi: 10.1097/ALN.0000000000000686.
• Meng L, Yu W, Wang T, Zhang L, Heerdt PM, Gelb AW. Blood Pressure Targets in Perioperative Care. Hypertension. 2018 Oct;72(4):806-817. doi: 10.1161/HYPERTENSIONAHA.118.11688. No abstract available.
• Wijnberge M, Schenk J, Bulle E, Vlaar AP, Maheshwari K, Hollmann MW, Binnekade JM, Geerts BF, Veelo DP. Association of intraoperative hypotension with postoperative morbidity and mortality: systematic review and meta-analysis. BJS Open. 2021 Jan 8;5(1):zraa018. doi: 10.1093/bjsopen/zraa018.
• Tassoudis V, Vretzakis G, Petsiti A, Stamatiou G, Bouzia K, Melekos M, Tzovaras G. Impact of intraoperative hypotension on hospital stay in major abdominal surgery. J Anesth. 2011 Aug;25(4):492-9. doi: 10.1007/s00540-011-1152-1. Epub 2011 May 6.
• Roach JK, Thiele RH. Perioperative blood pressure monitoring. Best Pract Res Clin Anaesthesiol. 2019 Jun;33(2):127-138. doi: 10.1016/j.bpa.2019.05.001. Epub 2019 May 7.
• Romagnoli S, Ricci Z, Quattrone D, Tofani L, Tujjar O, Villa G, Romano SM, De Gaudio AR. Accuracy of invasive arterial pressure monitoring in cardiovascular patients: an observational study. Crit Care. 2014 Nov 30;18(6):644. doi: 10.1186/s13054-014-0644-4.
• Truijen J, van Lieshout JJ, Wesselink WA, Westerhof BE. Noninvasive continuous hemodynamic monitoring. J Clin Monit Comput. 2012 Aug;26(4):267-78. doi: 10.1007/s10877-012-9375-8. Epub 2012 Jun 14.
• Naylor AJ, Sessler DI, Maheshwari K, Khanna AK, Yang D, Mascha EJ, Suleiman I, Reville EM, Cote D, Hutcherson MT, Nguyen BM, Elsharkawy H, Kurz A. Arterial Catheters for Early Detection and Treatment of Hypotension During Major Noncardiac Surgery: A Randomized Trial. Anesth Analg. 2020 Nov;131(5):1540-1550. doi: 10.1213/ANE.0000000000004370.
• Wax DB, Lin HM, Leibowitz AB. Invasive and concomitant noninvasive intraoperative blood pressure monitoring: observed differences in measurements and associated therapeutic interventions. Anesthesiology. 2011 Nov;115(5):973-8. doi: 10.1097/ALN.0b013e3182330286.
• Meidert AS, Dolch ME, Muhlbauer K, Zwissler B, Klein M, Briegel J, Czerner S. Oscillometric versus invasive blood pressure measurement in patients with shock: a prospective observational study in the emergency department. J Clin Monit Comput. 2021 Apr;35(2):387-393. doi: 10.1007/s10877-020-00482-2. Epub 2020 Feb 13. Erratum In: J Clin Monit Comput. 2022 Feb;36(1):287. doi: 10.1007/s10877-021-00766-1.
• Rutten AJ, Ilsley AH, Skowronski GA, Runciman WB. A comparative study of the measurement of mean arterial blood pressure using automatic oscillometers, arterial cannulation and auscultation. Anaesth Intensive Care. 1986 Feb;14(1):58-65. doi: 10.1177/0310057X8601400113.
• Gabriel A, Lindblad LE, Angleryd C. Non-invasive vs. invasive beat-to-beat monitoring of blood pressure. Clin Physiol. 1992 Mar;12(2):229-35. doi: 10.1111/j.1475-097x.1992.tb00309.x.
• Francke A, Wachsmuth H. [How accurate is invasive blood pressure determination with fluid-filled pressure line systems?]. Anaesthesiol Reanim. 2000;25(2):46-54. German.
• Mireles SA, Jaffe RA, Drover DR, Brock-Utne JG. A poor correlation exists between oscillometric and radial arterial blood pressure as measured by the Philips MP90 monitor. J Clin Monit Comput. 2009 Jun;23(3):169-74. doi: 10.1007/s10877-009-9178-8. Epub 2009 Apr 25.
• Ribezzo S, Spina E, Di Bartolomeo S, Sanson G. Noninvasive techniques for blood pressure measurement are not a reliable alternative to direct measurement: a randomized crossover trial in ICU. ScientificWorldJournal. 2014 Jan 30;2014:353628. doi: 10.1155/2014/353628. eCollection 2014.
• Velasco A, Ono C, Nugent K, Tarwater P, Kumar A. Ultrasonic evaluation of the radial artery diameter in a local population from Texas. J Invasive Cardiol. 2012 Jul;24(7):339-41.
• Pancholy SB, Shah S, Patel TM. Radial Artery Access, Hemostasis, and Radial Artery Occlusion. Interv Cardiol Clin. 2015 Apr;4(2):121-125. doi: 10.1016/j.iccl.2015.01.004. Epub 2015 Mar 31.

Helpful Links

• Guidelines to Anesthesia | Canadian Anesthesiologists' Society.
• Coronary Interventions Handbook ; An Interventional Council Review
• Bickley, Lynn S. Bates' Guide to Physical Examination and History Taking. Philadelphia: Lippincott Williams & Wilkins, 2020.
• 26. Schroeder, Becky, et al. "Chapter 36 - Cardiovascular Monitoring." Miller's Anesthesia, Elsevier, Philadelphia, Pennsylvania , 2020, pp. 1145-1193. From Gropper, Michael A., and Ronald D. Miller. Miller's Anesthesia. Elsevier, 2020.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: anesthesia; blood pressure; invasive blood pressure; noninvasive blood pressure
• Other Study ID Numbers: 2025-3776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No