Perioperative Arterial Pressure Monitoring
Conditions
Keywords
Radial Artery Cannulation, Modified Cannulation Site ，Catheter Stability, Invasive Blood Pressure Monitoring, arterial catheter function
Brief 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. 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
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.
Interventions
PROCEDUREThe 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
PROCEDUREtraditional site
The ultrasound-guided radial artery puncture site is level with the radial styloid process and where the radial artery pulse is most prominent
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of arterial catheter dysfunction | during the period of catheter indwelling | (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of arterial catheter dysfunction | during the period of catheter indwelling | mean number of catheter instability events per subject per hour. |
| Damping abnormality rate and frequency | during the period of catheter indwelling | 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. |
| First-puncture success rate | From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes | 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. |
| Number of arterial punctures | From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes | 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. |
| Arterial Cannulation Time | From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes | 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. |
| Complication incidence | from the time of the puncture onset until the time of every day after arterial puncture (at 1-day, 2-day, 3-day | 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. |
| Difference in IABP before and after square wave test. | during the period of catheter indwelling | The difference between the invasive blood pressure value before wave test and the invasive blood pressure value after waveform stabilization |
| Difference between IABP and NIBP | during the period of catheter indwelling | The difference between the invasive blood pressure value and the cuff pressure after waveform stabilization |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORSanqing Jin, MD
The Sixth Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed