Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics
Oblique Versus Transverse Transducer Orientation Approach for Ultrasound Guided Internal Jugular Venous Cannulation in Heart Surgery Pediatric Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedFirst Submitted
Initial submission to the registry
July 18, 2021
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedDecember 19, 2022
December 1, 2022
4 months
July 18, 2021
December 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% of patients with successful cannulation in first attempt
The number of patients undergo cannulation with first attempt success are shown in percentage
at the procedure of cannulation
Secondary Outcomes (1)
% of patients with successful cannulation with designed approach
at the procedure of cannulation
Study Arms (2)
Oblique orientation
EXPERIMENTALcannulation will be oblique approach
transverse approach
ACTIVE COMPARATORcannulation will be transverse approach
Interventions
internal jugular venous cannulation
Eligibility Criteria
You may qualify if:
- patients age 3 months to 12 years old, weight 5-20 kg, male or female
- who undergo heart surgery and indicated to have central venous cannulation
- American Society of Anesthesiologist Physical Class 1-3
- Family or representation of the patients agreed to participate in this study and sign informed consent
You may not qualify if:
- history of surgery in the area of cannulation
- already placed central venous cannulation \<72 hours in the same venous
- sign of infection, hematoma, emphysema, in the area of cannulation
- history of cervical trauma
- severe hemostatic disorder (International Normalized Ratio\>2, thrombocyte \<50.000, Prothrombin time\>1.5 times, Activated Partial Thromboplastin Time \> 1.5 times
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Central National Hospital
Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
aldy heriwardito, Doctor
Indonesia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 18, 2021
First Posted
December 19, 2022
Study Start
February 1, 2021
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
December 19, 2022
Record last verified: 2022-12