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AnesthesiaPROMISESNCT06518980

Prospective Validation of Intraoperative Blood Pressure Monitors

An observational study of Anesthesia and Blood Pressure, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Blood Pressure
How many people
60 participants
Where
1 siteCanada
Study dates
Jul 2024to Oct 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pascal Laferrière-Langlois contact

+1-819-432-5847

pascal.laferriere-langlois@umontreal.ca

Nadia Godin contact

514-252-3400 ext. 3193

ngodin.hmr@ssss.gouv.qc.ca

Canada1 site

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

    Montreal East, Quebec, H1T2M4

    Pascal Laferrière-Langlois, MD, FRQS, +1-819-432-5847, pascal.laferriere-langlois@umontreal.ca

    Pascal Laferrière-Langlois, MD, FRQS

Other trials in Canada

About this study

Official title: 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.
Read the 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.

Keywords
anesthesia, blood pressure, noninvasive blood pressure, invasive blood pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. 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

    Measured: 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)

  1. 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

    Measured: 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.

  2. 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.

    Measured: From installation of patient's arterial line until removal of patient's arterial line, expected duration approximately between 1 and 8 hours.

  3. 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.

    Measured: From patient file analysis at time of recruitment until the end of statistical analysis. Expected duration: up to a year.

  4. 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.

    Measured: From measurement of patient's radial artery via ultrasonography before induction until the end of statistical analysis. Expected duration: up to a year.

  5. 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

    Measured: 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.

  6. 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.

    Measured: From patient file analysis at time of recruitment until the end of statistical analysis. Expected duration up to a year.

  7. 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.

    Measured: From anesthesia induction until patient's departure from PACU and/or removal of arterial line, expected duration between 2 and 8 hours.

  8. 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

    Measured: from installation of radial line until removal of arterial line. Expected duration between 5 and 15 minutes.

  9. 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

    Measured: Time Frame : from installation of radial line until removal of radial line. Expected duration between 1 and 8 hours.

  10. 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

    Measured: from installation of radial line until patient's departure from PACU and/or removal of arterial line. Expected duration between 1 andd 8 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06518980
Sponsor's protocol ID
2025-3776
Acronym
PROMISES
Status last verified
Jul 2024
First submitted
9 Jul 2024
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30354725

  • 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.

    PubMed 25929547

  • 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.

    PubMed 21547554

  • 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.

    PubMed 27792044

  • 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.

    PubMed 26181335

  • 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.

    PubMed 23835589

  • 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.

    PubMed 26540148

  • Botto F, Alonso-Coello P, Chan MT, Villar JC, Xavier D, Srinathan S, Guyatt G, Cruz P, Graham M, Wang CY, Berwanger O, Pearse RM, Biccard BM, Abraham V, Malaga G, Hillis GS, Rodseth RN, Cook D, Polanczyk CA, Szczeklik W, Sessler DI, Sheth T, Ackland GL, Leuwer M, Garg AX, Lemanach Y, Pettit S, Heels-Ansdell D, Luratibuse G, Walsh M, Sapsford R, Schunemann HJ, Kurz A, Thomas S, Mrkobrada M, Thabane L, Gerstein H, Paniagua P, Nagele P, Raina P, Yusuf S, Devereaux PJ, Devereaux PJ, Sessler DI, Walsh M, Guyatt G, McQueen MJ, Bhandari M, Cook D, Bosch J, Buckley N, Yusuf S, Chow CK, Hillis GS, Halliwell R, Li S, Lee VW, Mooney J, Polanczyk CA, Furtado MV, Berwanger O, Suzumura E, Santucci E, Leite K, Santo JA, Jardim CA, Cavalcanti AB, Guimaraes HP, Jacka MJ, Graham M, McAlister F, McMurtry S, Townsend D, Pannu N, Bagshaw S, Bessissow A, Bhandari M, Duceppe E, Eikelboom J, Ganame J, Hankinson J, Hill S, Jolly S, Lamy A, Ling E, Magloire P, Pare G, Reddy D, Szalay D, Tittley J, Weitz J, Whitlock R, Darvish-Kazim S, Debeer J, Kavsak P, Kearon C, Mizera R, O'Donnell M, McQueen M, Pinthus J, Ribas S, Simunovic M, Tandon V, Vanhelder T, Winemaker M, Gerstein H, McDonald S, O'Bryne P, Patel A, Paul J, Punthakee Z, Raymer K, Salehian O, Spencer F, Walter S, Worster A, Adili A, Clase C, Cook D, Crowther M, Douketis J, Gangji A, Jackson P, Lim W, Lovrics P, Mazzadi S, Orovan W, Rudkowski J, Soth M, Tiboni M, Acedillo R, Garg A, Hildebrand A, Lam N, Macneil D, Mrkobrada M, Roshanov PS, Srinathan SK, Ramsey C, John PS, Thorlacius L, Siddiqui FS, Grocott HP, McKay A, Lee TW, Amadeo R, Funk D, McDonald H, Zacharias J, Villar JC, Cortes OL, Chaparro MS, Vasquez S, Castaneda A, Ferreira S, Coriat P, Monneret D, Goarin JP, Esteve CI, Royer C, Daas G, Chan MT, Choi GY, Gin T, Lit LC, Xavier D, Sigamani A, Faruqui A, Dhanpal R, Almeida S, Cherian J, Furruqh S, Abraham V, Afzal L, George P, Mala S, Schunemann H, Muti P, Vizza E, Wang CY, Ong GS, Mansor M, Tan AS, Shariffuddin II, Vasanthan V, Hashim NH, Undok AW, Ki U, Lai HY, Ahmad WA, Razack AH, Malaga G, Valderrama-Victoria V, Loza-Herrera JD, De Los Angeles Lazo M, Rotta-Rotta A, Szczeklik W, Sokolowska B, Musial J, Gorka J, Iwaszczuk P, Kozka M, Chwala M, Raczek M, Mrowiecki T, Kaczmarek B, Biccard B, Cassimjee H, Gopalan D, Kisten T, Mugabi A, Naidoo P, Naidoo R, Rodseth R, Skinner D, Torborg A, Paniagua P, Urrutia G, Maestre ML, Santalo M, Gonzalez R, Font A, Martinez C, Pelaez X, De Antonio M, Villamor JM, Garcia JA, Ferre MJ, Popova E, Alonso-Coello P, Garutti I, Cruz P, Fernandez C, Palencia M, Diaz S, Del Castillo T, Varela A, de Miguel A, Munoz M, Pineiro P, Cusati G, Del Barrio M, Membrillo MJ, Orozco D, Reyes F, Sapsford RJ, Barth J, Scott J, Hall A, Howell S, Lobley M, Woods J, Howard S, Fletcher J, Dewhirst N, Williams C, Rushton A, Welters I, Leuwer M, Pearse R, Ackland G, Khan A, Niebrzegowska E, Benton S, Wragg A, Archbold A, Smith A, McAlees E, Ramballi C, Macdonald N, Januszewska M, Stephens R, Reyes A, Paredes LG, Sultan P, Cain D, Whittle J, Del Arroyo AG, Sessler DI, Kurz A, Sun Z, Finnegan PS, Egan C, Honar H, Shahinyan A, Panjasawatwong K, Fu AY, Wang S, Reineks E, Nagele P, Blood J, Kalin M, Gibson D, Wildes T; Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Writing Group, on behalf of The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Investigators; Appendix 1. The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study Investigators Writing Group; Appendix 2. The Vascular events In noncardiac Surgery patIents cOhort evaluatioN Operations Committee; Vascular events In noncardiac Surgery patIents cOhort evaluatioN VISION Study Investigators. Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes. Anesthesiology. 2014 Mar;120(3):564-78. doi: 10.1097/ALN.0000000000000113.

    PubMed 24534856

  • 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.

    PubMed 33609377

  • 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.

    PubMed 31582093

  • 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.

    PubMed 25433536

  • 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.

    PubMed 22695821

  • 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.

    PubMed 33079877

  • 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.

    PubMed 21952254

  • 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.

    PubMed 32056094

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia and Blood Pressure, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pascal Laferrière-Langlois (+1-819-432-5847, pascal.laferriere-langlois@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06518980, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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