Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652490
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Short-axisout-of-plane Approach Versus Oblique- Axis Approach for US Guided IJV Catheterization in Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Short-axisout-of-plane Approach Versus Oblique- Axis Approach for Ultrasound-guided Internal Jugular Venous Catheterization in Infants
Status:
RECRUITING
Status Verified Date:
2024-02
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:
The investigators will measure and compare the rate of acute complications success rate number of attempts to successful cannulation between ultrasound-guided short axis approach and oblique axis approach during internal jugular venous catheterization in infants
Detailed Description:
1 pre-procedure settings The history will be obtained from patients parents Investigations will be checked to all patients as complete blood picture and coagulation profile to avoid coagulopathy and thrombocytopenia
All patients will be attached to standard monitoring blood pressure non-invasive heart rate and pulse oximetry
Groups
Patients will be assigned randomly by using a computer -generated table of random numbers into two groups
Group A control group n25 CVL insertion in the right internal jugular vein using ultrasound The US probe is placed perpendicular to the venous anatomy in the SAX approach
Group B comparative group n25 CVL insertion in the right internal jugular vein using ultrasound The US probe is aligned at 45 angulationclockwise with the venous anatomy in the OAX approach
2 procedure Settings Monitor will be connected and pulse oximetry SPO2 baseline non-invasive blood pressure NIBP heartrate HR electrocardiogram ECG will be obtained
In this study we will use US machine with small linear probe with frequency 5 - 10 Hz and the procedure will be held by the most senior Anaesthesiologist experience in pediatric central venous catheterization for at least 3 years
The procedure will be held under aseptic condition Using US after GA in OR the anatomical location and patency of the IJV will be assessed with the patient placed in the Trendelenburg position with the head slightly rotated to the contralateral side With all sterile precautions a 4 french introducer needle mounted on a syringe is inserted into the IJV guided by real time US imaging Once blood is freely aspirated the US probe is set aside and the syringe removed from the needle Then the guide wire will be advanced through the needle into the vessel and the catheter will be advanced using the Seldinger technique after guidewire position is confirmed with US The guidewire will be then removed Using US placement of the catheter in the vein will confirmed following which the catheter will be secured in place using sutures The position of the CVC wiil be also confirmed by a chest radiograph at the end of the procedure
In the group A The US probe will be placed perpendicular to the venous anatomy in the SAX approach
In the group B The US probe will be aligned at 45 angulation with the venous anatomy and combined with an in plane needle insertion technique The needle will be advanced from lateral to medial
All patients will be attached to standard monitoring blood pressure non-invasive heart rate and pulse oximetry
Groups
Patients will be assigned randomly by using a computer -generated table of random numbers into two groups
Group A control group n25 CVL insertion in the right internal jugular vein using ultrasound The US probe is placed perpendicular to the venous anatomy in the SAX approach
Group B comparative group n25 CVL insertion in the right internal jugular vein using ultrasound The US probe is aligned at 45 angulationclockwise with the venous anatomy in the OAX approach
2 procedure Settings Monitor will be connected and pulse oximetry SPO2 baseline non-invasive blood pressure NIBP heartrate HR electrocardiogram ECG will be obtained
In this study we will use US machine with small linear probe with frequency 5 - 10 Hz and the procedure will be held by the most senior Anaesthesiologist experience in pediatric central venous catheterization for at least 3 years
The procedure will be held under aseptic condition Using US after GA in OR the anatomical location and patency of the IJV will be assessed with the patient placed in the Trendelenburg position with the head slightly rotated to the contralateral side With all sterile precautions a 4 french introducer needle mounted on a syringe is inserted into the IJV guided by real time US imaging Once blood is freely aspirated the US probe is set aside and the syringe removed from the needle Then the guide wire will be advanced through the needle into the vessel and the catheter will be advanced using the Seldinger technique after guidewire position is confirmed with US The guidewire will be then removed Using US placement of the catheter in the vein will confirmed following which the catheter will be secured in place using sutures The position of the CVC wiil be also confirmed by a chest radiograph at the end of the procedure
In the group A The US probe will be placed perpendicular to the venous anatomy in the SAX approach
In the group B The US probe will be aligned at 45 angulation with the venous anatomy and combined with an in plane needle insertion technique The needle will be advanced from lateral to medial
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