Trial Outcomes & Findings for Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients (NCT NCT02687126)

NCT ID: NCT02687126

Last Updated: 2017-04-25

Results Overview

An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 106 participants
• Primary outcome timeframe: up to 24 hours after intervention
• Results posted on: 2017-04-25

Participant Flow

Participant milestones

Measure	Ultrasound Guided Central Venous Catheterization Six month study of ultrasound guided internal jugular venous catheterization in pediatric cardiac surgical patients
Data Collection STARTED	106
Data Collection COMPLETED	106
Data Collection NOT COMPLETED	0
Data Analysis STARTED	106
Data Analysis COMPLETED	106
Data Analysis NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients

Baseline characteristics by cohort

Measure	Demographic Variables n=106 Participants gender, age, weight, height, cross sectional area, body surface area
Age, Continuous	60 Months n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Height	102 Centimeters n=5 Participants
Weight	15 Kilograms n=5 Participants
Body surface area	0.655 Square of meter n=5 Participants
Cross sectional area of the Internal Jugular Vein	0.775 Square of centimeter n=5 Participants

PRIMARY outcome

Timeframe: up to 24 hours after intervention

An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur

Outcome measures

Measure	Number of Attempts n=106 Participants An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
Number of Attempts for Successful Central Venous Cannulation	1.29 Attempts Standard Deviation 0.59

SECONDARY outcome

Timeframe: up to 1 hour after intervention

Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal

Outcome measures

Measure	Number of Attempts n=106 Participants An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
Time to Successful Cannulation	134.06 Seconds Standard Deviation 81.59

SECONDARY outcome

Timeframe: up to 24 hours after intervention

Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma

Outcome measures

Measure	Number of Attempts n=106 Participants An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
Number of Patients With Complications	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Number of Attempts n=106 Participants An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
Cross Sectional Area of Internal Jugular Vein Number of attempts	-0.192 Pearson's correlation Coefficient
Cross Sectional Area of Internal Jugular Vein Time for successful cannulation	-0.35 Pearson's correlation Coefficient
Cross Sectional Area of Internal Jugular Vein Overall complications	0.095 Pearson's correlation Coefficient

Adverse Events

Number of Complications

Serious events: 11 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Number of Complications n=106 participants at risk Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
Blood and lymphatic system disorders Arterial puncture	10.4% 11/106 • Number of events 11
Respiratory, thoracic and mediastinal disorders Hemothorax	0.94% 1/106 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.94% 1/106 • Number of events 1

Other adverse events

Measure	Number of Complications n=106 participants at risk Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
Skin and subcutaneous tissue disorders Local site hematoma	10.4% 11/106 • Number of events 11

Additional Information

Santosh Sharma Parajuli

Shahid Gangalal National Heart Centre

Phone: +9779806532132

Email: santoshparajuli77@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place