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Perioperative Arterial Pressure MonitoringNCT06566456

Effect of Modified Radial Artery Cannulation Site on IABP Monitoring Stability

A study testing The puncture site is 1.5-2.5 cm proximal to the radial styloid process and traditional site in people with Perioperative Arterial Pressure Monitoring, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Invasive arterial blood pressure (IABP) monitoring is critical for perioperative and critically ill patients, yet traditional radial artery cannulation near the wrist joint is prone to catheter dysfunction (e.g., kinking, occlusion) due to positional changes, compromising accuracy and patient safety. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
The puncture site is 1.5-2.5 cm proximal to the radial styloid process and traditional site
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
486 participants
Where
1 siteChina
Study dates
15 Sep 2025to 27 Nov 2025
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18-75 years of age undergoing elective surgery who require radial artery cannulation;
  • Patients positioned in supine, lithotomy, or other face-up surgical postures;
  • American Society of Anesthesiologists (ASA) physical status classification: Grades I to III.

Who cannot join

  • Abnormal results from the modified Allen test;
  • Patients with a history of radial artery cannulation within the past 3 months, or with infection/trauma at or adjacent to the puncture site;
  • Coagulopathy or hypercoagulable state;
  • Patients undergoing anticoagulant therapy;
  • Comorbid vascular diseases (e.g., vasculitis);
  • Patients undergoing surgical procedures involving the same anatomic region;
  • Preoperative hemodynamic instability (including patients already on vasoactive medications, or with atrial fibrillation, atrial flutter, atrioventricular block of grade II or higher, multifocal ventricular premature beats, or ventricular premature beats with R-on-T phenomenon);
  • Patients lacking legal capacity to sign informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: The Impact of Modified Site for Radial Artery Cannulation on the Stability of Arterial Blood Pressure Monitoring

Invasive arterial blood pressure (IABP) monitoring is critical for perioperative and critically ill patients, yet traditional radial artery cannulation near the wrist joint is prone to catheter dysfunction (e.g., kinking, occlusion) due to positional changes, compromising accuracy and patient safety. This trial hypothesizes that modifying the cannulation site to 1.5-2.5 cm proximal to the radial styloid process may enhance catheter stability.

Read the detailed description

Methods and analysis:This is a prospective, parallel-group, randomized, controlled, analyst-blinded trial. A total of 486 participants (231 per group, adjusted for 5% dropout) will be enrolled. Eligible patients (18-75 years, ASA physical status I-III, requiring elective surgery with radial artery cannulation) will be randomized 1:1 to the modified group (1.5-2.5 cm proximal to the radial styloid process) or the conventional group (traditional site). The primary outcome is the incidence of arterial catheter dysfunction (defined by criteria such as blood sampling difficulty, position-dependent waveform, or improved waveform post-square wave test). Secondary outcomes include frequency of catheter dysfunction, damping abnormality rate, first-puncture success rate, number of arterial punctures,arterial cannulation time, complication incidence, and blood pressure measurement differences.

Sample size calculation:This trial utilized a superiority test for sample size calculation. In the 100-case preliminary experiment results, the incidence rate of abnormal arterial catheter function was 30% in the control group and 12% in the modified group. With a predefined superiority margin Δ of -6% (actual observed Δ of -18%), using a type I error rate (α) of 0.025 and statistical power (1-β) of 0.90, statistical calculations determined that 231 participants per group (totaling 462) would be required to detect this difference in a two-sided test. Considering a 5% dropout rate among study subjects, the final planned sample size was adjusted to 486 cases.

Being tested
The puncture site is 1.5-2.5 cm proximal to the radial styloid process, traditional site
Keywords
Radial Artery Cannulation, Modified Cannulation Site ，Catheter Stability, Invasive Blood Pressure Monitoring, arterial catheter function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The puncture site is 1.5-2.5 cm proximal to the radial styloid processProcedure or surgery

    The ultrasound-guided radial artery puncture site is1.5-2.5 cm proximal to the radial styloid process

  • traditional siteProcedure or surgery

    The ultrasound-guided radial artery puncture site is level with the radial styloid process and where the radial artery pulse is most prominent

Study groups in NCT06566456
Study groupRoleWhat they receive
1.5-2.5 cm proximal to the radial styloid processExperimentalThe ultrasound-guided radial artery puncture site is1.5-2.5 cm proximal to the radial styloid process
Receives: Procedure: The puncture site is 1.5-2.5 cm proximal to the radial styloid process
traditional siteActive comparatorThe ultrasound-guided radial artery puncture site is level with the radial styloid process and where the radial artery pulse is most prominent
Receives: Procedure: traditional site

What is being measured

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

  1. Incidence of arterial catheter dysfunction

    (a) difficulty in blood sampling: When drawing arterial blood samples for blood gas analysis, the sample cannot be aspirated smoothly through the arterial pressure monitoring line, necessitating repeated flushing of the line to obtain an adequate sample; or arterial catheter occlusion occurs and a new arterial pressure monitoring pathway must be established based on surgical or anesthetic requirements; (b) position-dependent waveform or flushing: repositioning of the arterial catheter or wrist is required to obtain a satisfactory arterial waveform, or smooth flushing can only be achieved following such repositioning. (c) improved waveform post-square wave test: after a square wave test (conducted every 30 minutes or when the arterial waveform becomes flat), the arterial waveform shows significant improvement compared to its pre-flush state.

    Measured: during the period of catheter indwelling

Secondary outcomes (8)

  1. Frequency of arterial catheter dysfunction

    mean number of catheter instability events per subject per hour.

    Measured: during the period of catheter indwelling

  2. Damping abnormality rate and frequency

    Damping abnormality rate: the ratio of total cases with over-damping or under-damping to the total number of enrolled patients per group.

    Damping abnormality frequency: mean number of over-damping or under-damping events per subject per hour.

    Measured: during the period of catheter indwelling

  3. First-puncture success rate

    the ratio of cases with successful first-time arterial cannulation to the number of enrolled cases per group. A successful first puncture is defined as achieving arterial access and catheter placement without needle withdrawal or repositioning after initial skin entry.

    Measured: From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes

  4. Number of arterial punctures

    total number of arterial punctures performed before successful cannulation. One puncture is defined as withdrawing the needle to the subcutaneous layer and reinserting it during the cannulation process.

    Measured: From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes

  5. Arterial Cannulation Time

    defined as the interval from the first skin entry of the needle to the first display of an arterial blood pressure waveform on the monitor.

    Measured: From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes

  6. Complication incidence

    encompasses complications during puncture and catheter indwelling (e.g., hematoma, bleeding, ecchymosis) and post-puncture complications (e.g., bleeding, hematoma, distal ischemia, local infection, peripheral nerve injury, unintended catheter dislodgment). The observation window is 0-3 days post-surgery.

    Measured: from the time of the puncture onset until the time of every day after arterial puncture (at 1-day, 2-day, 3-day

  7. Difference in IABP before and after square wave test.

    The difference between the invasive blood pressure value before wave test and the invasive blood pressure value after waveform stabilization

    Measured: during the period of catheter indwelling

  8. Difference between IABP and NIBP

    The difference between the invasive blood pressure value and the cuff pressure after waveform stabilization

    Measured: during the period of catheter indwelling

Timeline

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

  1. First posted22 Aug 2024
  2. Study start15 Sep 2025
  3. Primary completion15 Sep 2025
  4. Study completion27 Nov 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06566456
Sponsor's protocol ID
2025ZSLYEC-505
Status last verified
Mar 2026
First submitted
20 Aug 2024
Last updated
17 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified participant data and statistical/analytic code will be available upon publication. Researchers who provide a methodologically sound proposal can request access by contacting Dr. Zhinan Zheng at zhengzhn5@mail.sysu.edu.cn. Data will be shared for specified purposes only and will require a signed data access agreement.

Publications

  • Andrews FJ, Nolan JP. Critical care in the emergency department: monitoring the critically ill patient. Emerg Med J. 2006 Jul;23(7):561-4. doi: 10.1136/emj.2005.029926.

    PubMed 16794104

  • Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.

    PubMed 20890190

  • Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

    PubMed 34599691

  • Araghi A, Bander JJ, Guzman JA. Arterial blood pressure monitoring in overweight critically ill patients: invasive or noninvasive? Crit Care. 2006;10(2):R64. doi: 10.1186/cc4896.

    PubMed 16630359

  • Antonelli M, Levy M, Andrews PJ, Chastre J, Hudson LD, Manthous C, Meduri GU, Moreno RP, Putensen C, Stewart T, Torres A. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive Care Med. 2007 Apr;33(4):575-90. doi: 10.1007/s00134-007-0531-4.

    PubMed 17285286

  • Cockings JG, Webb RK, Klepper ID, Currie M, Morgan C. The Australian Incident Monitoring Study. Blood pressure monitoring--applications and limitations: an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):565-9. doi: 10.1177/0310057X9302100512.

    PubMed 8273876

  • Hager HH, Burns B. Artery Cannulation. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482242/

    PubMed 29489243

  • Clark VL, Kruse JA. Arterial catheterization. Crit Care Clin. 1992 Oct;8(4):687-97.

    PubMed 1327430

  • Nuttall G, Burckhardt J, Hadley A, Kane S, Kor D, Marienau MS, Schroeder DR, Handlogten K, Wilson G, Oliver WC. Surgical and Patient Risk Factors for Severe Arterial Line Complications in Adults. Anesthesiology. 2016 Mar;124(3):590-7. doi: 10.1097/ALN.0000000000000967.

    PubMed 26640979

  • White L, Halpin A, Turner M, Wallace L. Ultrasound-guided radial artery cannulation in adult and paediatric populations: a systematic review and meta-analysis. Br J Anaesth. 2016 May;116(5):610-7. doi: 10.1093/bja/aew097.

    PubMed 27106964

  • Robertson-Malt S, Malt GN, Farquhar V, Greer W. Heparin versus normal saline for patency of arterial lines. Cochrane Database Syst Rev. 2014 May 13;2014(5):CD007364. doi: 10.1002/14651858.CD007364.pub2.

    PubMed 24825673

  • Alves M, Barbier C, Fangio P, Hayon J, Loubieres Y, Pichereau C, Maury E, Outin H. Arterial catheters' dysfunction according to insertion site: an observational study. Minerva Anestesiol. 2017 Feb;83(2):222-224. doi: 10.23736/S0375-9393.16.11606-2. Epub 2016 Oct 4. No abstract available.

    PubMed 27701374

  • Imbriaco G, Monesi A, Giugni A, Cilloni N. Radial artery cannulation in intensive care unit patients: Does distance from wrist joint increase catheter durability and functionality? J Vasc Access. 2021 Jul;22(4):561-567. doi: 10.1177/1129729820953020. Epub 2020 Aug 27.

    PubMed 32854566

  • Z.-N. Z ,X. L,J. L, et al.Abstract PR028: A Survey of the Incidence and Consequences of Invasive Blood Pressure Measuring Errors Caused By Arterial Line Occlusion[J].Anesthesia Analgesia,2016,123(3S2):45-45.

  • Yang X, Liang HM, Huang YB, Li S, Chen Y, Luo TF, Wang W, Li J, Zhao YY, Jin Y, Wang F, Yao YC, Jin SQ, Zheng ZN. Effects of modified site for radial artery cannulation on the stability of arterial blood pressure monitoring in patients undergoing elective surgery (MoSRAC): protocol for a randomised controlled trial. BMJ Open. 2026 Apr 15;16(4):e111900. doi: 10.1136/bmjopen-2025-111900.

    PubMed 41985968

Questions about this trial

What is this clinical trial studying?

A study testing The puncture site is 1.5-2.5 cm proximal to the radial styloid process and traditional site in people with Perioperative Arterial Pressure Monitoring, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Mar 2026. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of arterial catheter dysfunction (time frame: during the period of catheter indwelling). 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 NCT06566456, which also lists 15 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 17 Mar 2026.

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