Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652191
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Non Dilation on the Central Venous CatheterizationNDCVC-01
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Central Venous Puncture Dilation and Non Dilation on the Success Rate of Catheterization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
NDCVC-01
Brief Summary:
The central venous catheter is widely used and used in high dosage and various complications such as hematoma hemopneumothorax and arterial puncture may occur during puncture and use In addition to conventional techniques studies have been done to improve the success rate of puncture and reduce the incidence of complications by modifying different procedures However among the complications caused by the procedure of percutaneous catheter placement the fatal bleeding caused by skin dilation may threaten the patient s life There are few studies on dilators and skin dilation steps at home and abroad In this study the conventional puncture technique was improved and the skin dilation step was omitted hoping to reduce complications reduce puncture time improve efficiency and improve patient comfort on the premise of ensuring the success rate of catheterization
Detailed Description:
The Central venous catheter is widely used but there are various complications During the procedure of skin expansion with central venous catheterization the use of a dilator can lead to complications such as hematoma fatal bleeding discomfort or serious threat to the patients life The aim of this study was to eliminate the procedure of skin expansion to ensure the success rate of catheterization to reduce complications to reduce operation time to improve efficiency and to improve patients comfort
This study is a single-center prospective randomized controlled trialThe sample size was calculated by non-inferiority test1the success rate of central venous catheterization was 9798 according to Meta-analysis references2α 00253power 904missed follow-up rate 20 and ultimately 336 samples were included in the study168 patients in each group
Patients will receive written and verbal information about the trial before written consent is obtained Randomization will take place on the day of surgery and patients will be assigned to the intervention group direct catheterization with non-dilation or the control group catheterization after expanding the skin with a dilator The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a research assistant
Under ultrasound guidance The patient will undergo central venous catheterization by an experienced anesthesiologist based on grouping informationIn the control group catheter was inserted after skin expansion with dilator while in the test group catheter was inserted directly with non-dilatorThe success rate of catheterization the total time of catheterization and complications were recordedThe patients were followed up for 24 hours after surgery and asked about their comfort level
Shapiro-Wilk test is used to test normality for continuous variables with data expressed as mean standard deviation and independent t-test is used for statistical analysisFor categorical data the incidence of immediate complications is expressed as a percentage and chi square test is used to statistically analyze the incidence of various complicationsFor the Primary outcome success rate of catheterization the method of confidence interval is used If the lower limit of confidence interval negative non-inferiority threshold the non-inferiority is considered P 005 was considered statistically significant
This study is a single-center prospective randomized controlled trialThe sample size was calculated by non-inferiority test1the success rate of central venous catheterization was 9798 according to Meta-analysis references2α 00253power 904missed follow-up rate 20 and ultimately 336 samples were included in the study168 patients in each group
Patients will receive written and verbal information about the trial before written consent is obtained Randomization will take place on the day of surgery and patients will be assigned to the intervention group direct catheterization with non-dilation or the control group catheterization after expanding the skin with a dilator The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a research assistant
Under ultrasound guidance The patient will undergo central venous catheterization by an experienced anesthesiologist based on grouping informationIn the control group catheter was inserted after skin expansion with dilator while in the test group catheter was inserted directly with non-dilatorThe success rate of catheterization the total time of catheterization and complications were recordedThe patients were followed up for 24 hours after surgery and asked about their comfort level
Shapiro-Wilk test is used to test normality for continuous variables with data expressed as mean standard deviation and independent t-test is used for statistical analysisFor categorical data the incidence of immediate complications is expressed as a percentage and chi square test is used to statistically analyze the incidence of various complicationsFor the Primary outcome success rate of catheterization the method of confidence interval is used If the lower limit of confidence interval negative non-inferiority threshold the non-inferiority is considered P 005 was considered statistically significant
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