Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566456
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
The New Position of Radial Artery Puncture and Cannulation of the Patient with SurgeryRAPC-02
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 0-19cm 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 229 the incidence of instability in the test group was 136 2 α 00251- β 090 3 the loss of subjects was 5 and the sample size of 754 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 0-19cm above the second wrist transverse creaseThe 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 or anesthesia nurse with at least 3 years of puncture experienceNon-invasive arterial BP versus arterial BP values are recorded at 30-minute intervals and rapid flush tests are performed after successful punctureThe occurrence of catheter instability are recorded until the end of the procedurePatients are followed up within 24h 48h and 72h after catheter removal to observe any post-puncture complications on the arterial puncture side
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 229 the incidence of instability in the test group was 136 2 α 00251- β 090 3 the loss of subjects was 5 and the sample size of 754 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 0-19cm above the second wrist transverse creaseThe 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 or anesthesia nurse with at least 3 years of puncture experienceNon-invasive arterial BP versus arterial BP values are recorded at 30-minute intervals and rapid flush tests are performed after successful punctureThe occurrence of catheter instability are recorded until the end of the procedurePatients are followed up within 24h 48h and 72h after catheter removal to observe any post-puncture complications on the arterial puncture side
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None