NCT05656937

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2021

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

July 18, 2021

Last Update Submit

December 16, 2022

Conditions

Keywords

oblique orientationtransverse orientationinternal jugular venous cannulationultrasound guidedshort axisoblique axis

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

EXPERIMENTAL

cannulation will be oblique approach

Procedure: internal jugular venous cannulation

transverse approach

ACTIVE COMPARATOR

cannulation will be transverse approach

Procedure: internal jugular venous cannulation

Interventions

internal jugular venous cannulation

Oblique orientationtransverse approach

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • aldy heriwardito, Doctor

    Indonesia University

    PRINCIPAL INVESTIGATOR

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

Locations