Clinical trial NCT06566456: The New Position of Radial Artery Puncture and Cannulation of the Patient with Surgery（RAPC-02）
Official title: The Impact of the New Position of Radial Artery Puncture and Cannulation of the Patient with Surgery on the Stability of Arterial Blood Pressure Monitoring During Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radial Artery
Keywords: Radial Artery Puncture and Cannulation
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 1956
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Invasive arterial blood pressure monitoring is the gold standard for blood pressure monitoring. The radial artery is the most commonly used site of arterial puncture and catheterization. The traditional puncture site is located at 0-1.9cm above the second wrist transverse crease. Due to the large range of motion of the wrist joint, the ductus arteriosus bending, unstable blood pressure waveform, and puncture complications occur. We believe that changing the puncture site is beneficial to enhance the stability of the perioperative arterial catheter, improve the accuracy of blood pressure values, and reduce the puncture-related complications. The purpose of this randomized controlled trial is to study the effect of radial artery puncture 2-4cm above the second wrist transverse crease on perioperative arterial catheter stability, blood pressure numerical accuracy, puncture-related indicators, and complications, using the traditional radial artery puncture site as a control.

Detailed description: Invasive arterial blood pressure monitoring is the gold standard for blood pressure monitoring. Arterial catheter instability is a common problem in the process of Invasive arterial blood pressure monitoring, such as catheter bending or prolapse, catheter blockage, and the low level of arterial waveform or even disappear. This is an important factor affecting the accuracy of implantation artery blood pressure monitoring, and also poses a great threat to the medical safety of patients in the perioperative period. The replacement of catheter also increases the workload of medical staff and the burden of patients. The purpose of this randomized controlled trial is to study the effect of radial artery puncture 2-4cm above the second wrist transverse crease on perioperative arterial catheter stability, blood pressure numerical accuracy, puncture-related indicators, and complications, using the traditional radial artery puncture site as a control.

This study is a single-center, prospective, randomized controlled trial. The sample size was calculated by superiority test: (1) according to the results of a previous retrospective study of the research group, the incidence of instability in the control group was 22%; (2) Set the optimal efficacy boundary Δ to -4.4%, the actual efficacy boundary Δ to -10%, with α = 0.025 and 1 - β = 0.90; (3) the loss of subjects was 5%, and the sample size of 1956 cases should be included in the Anesthesia Surgery Center of the Sixth Affiliated Hospital of Sun Yat-sen University.

Patients will receive written and verbal information about the trial before written consent is obtained. The subjects will be then randomized into the trial group and the control group. The puncture point of the test group is located 2-4cm above the second wrist transverse crease, and the puncture point of the control group is located at 0-1.9cm above the second wrist transverse crease.The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.

Under ultrasound guidance, the patient will be undergone the radial artery puncture and cannulation by a highly senior resident with at least 3 years of puncture experience. Fast flush tests are performed and non-invasive arterial BP versus arterial BP values are recorded at 30-minute intervals after successful puncture.The occurrence of catheter instability are recorded until the end of the procedure.Patients are followed up within 24h, 48h and 72h after catheter removal to observe any post-puncture complications on the arterial puncture side.

Eligibility criteria: Inclusion Criteria:

* (1) Patients scheduled for elective surgery who, based on the clinical judgment of the physician, require invasive arterial pressure monitoring via the radial artery or repeated arterial blood gas analysis during the surgery; (2) Patients in the supine position during the surgery; (3) Patients with an American Society of Anesthesiologists (ASA) physical status classification of I-III; (4) Patients aged 18-75 years.

Exclusion Criteria:

* (1) Patients with a negative modified Allen's test; (2) Patients with a history of radial artery puncture within the past 3 months, or with infection or trauma at or near the puncture site; (3) Patients with coagulation disorders or a hypercoagulable state; (4) Patients receiving anticoagulant therapy; (5) Patients with concomitant vascular diseases, such as vasculitis; (6) Patients undergoing a surgical procedure involving the same anatomical region; (7) Patients with pre-existing hemodynamic instability, including those already receiving vasoactive medications and those with atrial fibrillation, atrial flutter, second-degree or higher atrioventricular block, multifocal premature ventricular contractions, or R-on-T premature ventricular contractions.

Primary outcomes:
measure: Incidence of catheter dysfunction
timeFrame: during the period of catheter indwelling
Secondary outcomes:
measure: Frequency of arterial catheter dysfunction
timeFrame: during the period of catheter indwelling
measure: Difference between arterial blood pressure and non-invasive blood pressure
timeFrame: during the period of catheter indwelling
measure: Incidence of damping abnormality
timeFrame: during the period of catheter indwelling
measure: First-attempt cannulation success rate
timeFrame: From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes
measure: Number of arterial punctures
timeFrame: From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes
measure: Puncture duration
timeFrame: From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes
measure: Complication occurrence
timeFrame: from the time of the puncture onset until the time of every 24 hours after arterial puncture (at 1-day, 2-day, 3-day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Sanqing Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hager HH, Burns B. Artery Cannulation(Archived). 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482242/
citation: Clark VL, Kruse JA. Arterial catheterization. Crit Care Clin. 1992 Oct;8(4):687-97.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.