- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274881
Surface Landmarks and C-length as Predictors of Depth of Right IJV Catheter Insertion: A TEE-Guided Study
Evaluation of Surface Landmarks and C-length as Predictors of the Depth of Right Internal Jugular Venous Catheter Insertion: A Transesophageal Echocardiography-Guided Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Before induction of anesthesia
Three sets of measurements will be obtained for each participant before induction of anesthesia:
- Surface measurements: Three points will be placed on the skin using a non-erasable marker. Point A, at the apex of the triangle between the two heads of the sternomastoid. Point B, at the ipsilateral sternoclavicular joint. Point C, at the lower border of the right 2nd rib at its junction with the sternum. The distance between point A and point B and between point B and point C will be measured and added to each other to determine the catheter length expected to place the tip at the mid-SVC.
- Radiological measurements: On the plain posteroanterior (PA) chest X-ray (CXR), the distance from the tip of the transverse process of T1 to the tracheal bifurcation (C-length) will be measured.
- Using Peres' formuls (Height in cm/10), we will record the anti After induction of anesthesia After induction of anaesthesia, the TEE probe will be placed and a bicaval view will be displayed to visualize the right atrium-superior vena cava (RA-SVC) junction and the proximal (lower) part of the SVC at its entry into the right atrium (RA). The TEE probe will be manipulated to display the SVC as far as possible from its junction with the RA.
The right internal jugular vein (IJV) will be cannulated under ultrasound guidance using the Seldinger technique.
After puncture of the IJV a J-wire will be advanced through the trocar until the J-end of the guidewire is visualized at the RA-IJV junction via the TEE.
The CVC catheter will be passed over the guidewire to the RA-SCV junction. The guidewire will be removed and the catheter will then be retracted under TEE guidance until the tip in visualized at 3.0 cm above the RA-SVC junction as measured with the TEE cursor. If the distal (upper) portion of the SVC could not be visualized, the catheter would be retracted for 3 cm as guided by the 1-cm gradations on the CVC.
Post-operative After operation, plain PA CXR will be obtained at the intensive care unit (ICU) to verify the position of the CVC tip in relation to the carina.
Statistical Analysis:
The length of the catheter required to place the tip at the mid SVC will be regressed on the C-length or the surface distance to obtain a predictive equation. The accuracy of either equation will be assessed by estimation of the standard error of the estimate (SEest).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 11517
- Ain Shams University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult subjects (age 18 years or older).
- Elective cardiac surgery.
- Echocardiography is indicated or recommended.
Exclusion Criteria:
- Previous cardiothoracic or neck surgery.
- Previous radiotherapy on the neck or chest.
- Intra-thoracic or neck mass lesions.
- Deformity of the chest wall.
- Anomalies of the great vessels.
- Congenital heart disease.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of surface landmarks for prediction of CVC depth required to place the CVC tip at the mid-SVC.
Time Frame: Outcome will be assessed at completion of catheterization procedure
|
Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall.
|
Outcome will be assessed at completion of catheterization procedure
|
|
Accuracy of C-length for prediction of CVC depth required to place the CVC tip at the mid-SVC.
Time Frame: Outcome will be assessed at completion of catheterization procedure
|
Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the C-length.
|
Outcome will be assessed at completion of catheterization procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sameh M Hakim, MD, Ain Shamd University, Faculty of Medicine, Department of Anesthesiology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FMASU MS 301/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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