Accidental Puncture of Artery During Catheter Insertion
Conditions
Brief summary
The purpose of the study is to evaluate the success rate using ultrasound as guidance during central venous cannulation in pediatric cardiac surgical patients.
Detailed description
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.
Interventions
DEVICECentral Venous Catheterization
Ultrasound guided internal jugular venous catheterization
Sponsors
Shahid Gangalal National Heart Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Patients requiring central venous catheterization for elective cardiac surgery. 2. Age below 15 years.
Exclusion criteria
1. Patient's guardian's refusal 2. Bleeding disorders 3. Clotting abnormalities (platelets count \< 75,000/cumm, INR \> 2) 4. Local site of infection 5. Underlying pneumothorax, pleural effusion or preoperative insertion of chest tube
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts for Successful Central Venous Cannulation | up to 24 hours after intervention | An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Cannulation | up to 1 hour after intervention | Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal |
| Number of Patients With Complications | up to 24 hours after intervention | Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cross Sectional Area of Internal Jugular Vein | up to 1 hour before intervention | Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate |
Countries
Nepal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Demographic Variables gender, age, weight, height, cross sectional area, body surface area | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | Demographic Variables |
|---|---|
| Age, Continuous | 60 Months |
| Body surface area | 0.655 Square of meter |
| Cross sectional area of the Internal Jugular Vein | 0.775 Square of centimeter |
| Height | 102 Centimeters |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 41 Participants |
| Weight | 15 Kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 11 / 106 |
| serious Total, serious adverse events | 11 / 106 |
Outcome results
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
Time frame: up to 24 hours after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Number of Attempts | Number of Attempts for Successful Central Venous Cannulation | 1.29 Attempts | Standard Deviation 0.59 |
Secondary
Number of Patients With Complications
Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma
Time frame: up to 24 hours after intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Number of Attempts | Number of Patients With Complications | 11 Participants |
Secondary
Time to Successful Cannulation
Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal
Time frame: up to 1 hour after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Number of Attempts | Time to Successful Cannulation | 134.06 Seconds | Standard Deviation 81.59 |
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
Time frame: up to 1 hour before intervention
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Number of Attempts | Cross Sectional Area of Internal Jugular Vein | Time for successful cannulation | -0.35 Pearson's correlation Coefficient |
| Number of Attempts | Cross Sectional Area of Internal Jugular Vein | Number of attempts | -0.192 Pearson's correlation Coefficient |
| Number of Attempts | Cross Sectional Area of Internal Jugular Vein | Overall complications | 0.095 Pearson's correlation Coefficient |