NCT02687126

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

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

First Submitted

Initial submission to the registry

January 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 25, 2017

Completed
Last Updated

April 25, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

January 15, 2016

Results QC Date

January 22, 2017

Last Update Submit

March 14, 2017

Conditions

Accidental Puncture of Artery During Catheter Insertion

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Time to Successful Cannulation

    up to 1 hour after intervention

  • Number of Patients With Complications

    up to 24 hours after intervention

Other Outcomes (1)

  • Cross Sectional Area of Internal Jugular Vein

    up to 1 hour before intervention

Study Arms (1)

Pediatric Cardiac Surgical Patients

OTHER

Central Venous Catheterization

Device: Central Venous Catheterization

Interventions

Central Venous CatheterizationDEVICE

Ultrasound guided internal jugular venous catheterization

Pediatric Cardiac Surgical Patients

Eligibility Criteria

Age1 Day - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients requiring central venous catheterization for elective cardiac surgery.
  • Age below 15 years.

You may not qualify if:

  • Patient's guardian's refusal
  • Bleeding disorders
  • Clotting abnormalities (platelets count \< 75,000/cumm, INR \> 2)
  • Local site of infection
  • Underlying pneumothorax, pleural effusion or preoperative insertion of chest tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Gangalal NationalHeart Centre

Kathmandu, Bagmati, 44606, Nepal

Location

Related Publications (2)

  • 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.

    PMID: 19237922RESULT

  • 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.

    PMID: 17872936RESULT

MeSH Terms

Interventions

Catheterization, Central Venous

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Limitations and Caveats

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.

Results Point of Contact

Title
Santosh Sharma Parajuli
Organization
Shahid Gangalal National Heart Centre
santoshparajuli77@hotmail.com
+9779806532132

Study Officials

  • Santosh S Parajuli, MD

    Shahid Gangalal National Heart Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 15, 2016

First Posted

February 22, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

April 25, 2017

Results First Posted

April 25, 2017

Record last verified: 2017-03

Locations

NE(1)