Prospective Validation of Intraoperative Blood Pressure Monitors

NCT06518980 | Not Yet Recruiting

• 1 other identifier: 2025-3776
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Blood Pressure

Keywords

anesthesia; blood pressure; noninvasive blood pressure; invasive blood pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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 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.

• 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.

• 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.

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Montreal East, Quebec, H1T2M4, Canada

Location

Related Publications (22)

• 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.

  PMID: 30354725 BACKGROUND

• 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.

  PMID: 25929547 BACKGROUND

• 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.

  PMID: 21547554 BACKGROUND

• 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.

  PMID: 27792044 BACKGROUND

• 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.

  PMID: 26181335 BACKGROUND

• 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.

  PMID: 23835589 BACKGROUND

• 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.

  PMID: 26540148 BACKGROUND

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  PMID: 24534856 BACKGROUND

• 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.

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• 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.

  PMID: 31582093 BACKGROUND

• 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.

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Related 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 Officials

• Pascal Laferrière-Langlois

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Laferrière-Langlois

CONTACT

+1-819-432-5847; pascal.laferriere-langlois@umontreal.ca

Nadia Godin

CONTACT

514-252-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRQS, Assistant Professor, Principal Investigator, Anesthesiologist

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 25, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)