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Umbilical Vessel Catheterization Under ECG Monitoring and Guidance

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ClinicalTrials.gov Identifier: NCT03898596
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

Brief Summary:
Umbilical venous catheters (UVC) are typically places with poor guidance and some radiological confirmation. Misplacement of the catheter could lead to its placement in other unintended anatomical areas such as the liver or the spleen, which could be detrimental in critically-ill infants. Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram (ECG) tracings.

Condition or disease Intervention/treatment Phase
Pediatric ALL Diagnostic Test: ECG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Umbilical Vessel Catheterization Under ECG Monitoring and Guidance
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ECG Monitoring
ECG readings will be collected for neonatal patients who require or currently have UVC
Diagnostic Test: ECG
An ECG collects superficial readings of heart activity




Primary Outcome Measures :
  1. Electrocardiogram Readings [ Time Frame: Duration of ECG placement and reading (typically 15 minutes) ]
    A normal heart rhythm contains a P wave, a QRS, and a T wave. Readings will include amplitude, deflection, and duration of such elements to record electrical heart activity.



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Ages Eligible for Study:   up to 45 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonate pediatric patient
  • 2 - 6kg
  • Require or currently have UVC

Exclusion Criteria:

  • Participants who do not consent or have parental consent
  • Patients who are clinically unstable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898596


Contacts
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Contact: Ahtziri Fonseca 6504970927 aef22011@stanford.edu

Sponsors and Collaborators
Stanford University

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Responsible Party: Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University
ClinicalTrials.gov Identifier: NCT03898596     History of Changes
Other Study ID Numbers: 49778
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chi-Ho Ban Tsui, Stanford University:
Neonates
Electrocardiogram
Umbilical Vein Catheterization