Effect of Modified Radial Artery Cannulation Site on IABP Monitoring Stability

NCT ID: NCT06566456

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Perioperative Arterial Pressure Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1.5-2.5 cm proximal to the radial styloid process

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

Group Type EXPERIMENTAL

The puncture site is 1.5-2.5 cm proximal to the radial styloid process

Intervention Type PROCEDURE

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

traditional site

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

Group Type ACTIVE_COMPARATOR

traditional site

Intervention Type PROCEDURE

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

Interventions

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The puncture site is 1.5-2.5 cm proximal to the radial styloid process

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

Intervention Type PROCEDURE

traditional site

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Abnormal results from the modified Allen test;
2. Patients with a history of radial artery cannulation within the past 3 months, or with infection/trauma at or adjacent to the puncture site;
3. Coagulopathy or hypercoagulable state;
4. Patients undergoing anticoagulant therapy;
5. Comorbid vascular diseases (e.g., vasculitis);
6. Patients undergoing surgical procedures involving the same anatomic region;
7. 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);
8. Patients lacking legal capacity to sign informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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SanQing Jin

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanqing Jin, MD

Role: PRINCIPAL_INVESTIGATOR

The Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sanqing Jin, MD

Role: CONTACT

0086-13719366863

Zhinan Zheng, MD

Role: CONTACT

0086-15915734893

Facility Contacts

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Sanqing Jin, MD

Role: primary

0086-13719366863

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

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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.

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Other Identifiers

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2025ZSLYEC-505

Identifier Type: -

Identifier Source: org_study_id

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