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The purpose of the study is to evaluate the success rate using ultrasound as guidance during central venous cannulation in pediatric cardiac surgical patients.
Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2.5% to 22%. The landmark technique has been standard approach for many years. In comparison with landmark method, in pediatric patients, the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. This study is designed to evaluate the success rate, complications, time taken for successful cannulation and their correlation with cross sectional area of the vein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Cardiac Surgical Patients | Other | Central Venous Catheterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Central Venous Catheterization | Device | Ultrasound guided internal jugular venous catheterization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempts for Successful Central Venous Cannulation | An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur | up to 24 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Successful Cannulation | Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal | up to 1 hour after intervention |
| Number of Patients With Complications |
| Measure | Description | Time Frame |
|---|---|---|
| Cross Sectional Area of Internal Jugular Vein | Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate | up to 1 hour before intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santosh S Parajuli, MD | Shahid Gangalal National Heart Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Gangalal NationalHeart Centre | Kathmandu | Bagmati | 44606 | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19237922 | Result | Froehlich CD, Rigby MR, Rosenberg ES, Li R, Roerig PL, Easley KA, Stockwell JA. Ultrasound-guided central venous catheter placement decreases complications and decreases placement attempts compared with the landmark technique in patients in a pediatric intensive care unit. Crit Care Med. 2009 Mar;37(3):1090-6. doi: 10.1097/CCM.0b013e31819b570e. | |
| 17872936 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Guided Central Venous Catheterization | Six month study of ultrasound guided internal jugular venous catheterization in pediatric cardiac surgical patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Data Collection |
|
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Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma
| up to 24 hours after intervention |
| Wigmore TJ, Smythe JF, Hacking MB, Raobaikady R, MacCallum NS. Effect of the implementation of NICE guidelines for ultrasound guidance on the complication rates associated with central venous catheter placement in patients presenting for routine surgery in a tertiary referral centre. Br J Anaesth. 2007 Nov;99(5):662-5. doi: 10.1093/bja/aem262. Epub 2007 Sep 14. |
| COMPLETED |
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| NOT COMPLETED |
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| Data Analysis |
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| ID | Title | Description |
|---|---|---|
| BG000 | Demographic Variables | gender, age, weight, height, cross sectional area, body surface area |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Months |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Height | Median | Full Range | Centimeters |
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| Weight | Median | Full Range | Kilograms |
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| Body surface area | Body surface area was calculated using Mosteller's formula | Median | Full Range | Square of meter |
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| Cross sectional area of the Internal Jugular Vein | Median | Full Range | Square of centimeter |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Attempts for Successful Central Venous Cannulation | An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur | Posted | Mean | Standard Deviation | Attempts | up to 24 hours after intervention |
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| Secondary | Time to Successful Cannulation | Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal | Posted | Mean | Standard Deviation | Seconds | up to 1 hour after intervention |
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| Secondary | Number of Patients With Complications | Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma | Posted | Count of Participants | Participants | up to 24 hours after intervention |
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| Other Pre-specified | Cross Sectional Area of Internal Jugular Vein | Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate | Posted | Number | Pearson's correlation Coefficient | up to 1 hour before intervention |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Number of Complications | Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma | 0 | 106 | 11 | 106 | 11 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial puncture | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local site hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Disease conditions of the patients may affect the size of the internal jugular vein. We did not evaluate the outcome variables in different disease conditions.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Santosh Sharma Parajuli | Shahid Gangalal National Heart Centre | +9779806532132 | santoshparajuli77@hotmail.com |
| ID | Term |
|---|---|
| D002405 | Catheterization, Central Venous |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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| Categories |
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| Categories |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Number of attempts |
| |||||
| Time for successful cannulation |
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| Overall complications |
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