Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way

Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.

Study Overview

• Status: Unknown
• Conditions: Heart Diseases; Diseases, Metabolic

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Pierre Kuhn, MD; Phone Number: 33 3 88 12 77 86; Email: Pierre.kuhn@chru-strasbourg.fr
• Study Contact Backup: Name: Olfa KOOBAR, MD; Phone Number: 33 3 88 12 77 57; Email: olfa.koobar@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de réanimation néonatale - HOPITAL DE HAUTEPIERRE
    • Contact: Pierre KUHN, MD, PhD; Phone Number: 33 3 88 12 77 79; Email: Pierre.Kuhn@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in the neonatal intensive care or neonatal intensive care.

The 3 types of taken most often encountered load are:

1. support for prematurity at birth or poor adaptation at birth requiring intensive care or ventilatory support.
2. management of congenital heart diseases including ducto-dependent, awaiting surgery.
3. care for severe medical condition exposing one or more organ failure, between 0 and 28 days of life (severe infections, metabolic diseases, severe dehydration ...)

Description

Inclusion Criteria:

• Patient hospitalized in the neonatal intensive care or neonatal intensive care at the University Hospital of Hautepierre
• All infants less than 44 weeks corrected age who require a surgical approach
• In the first line if neonate over 34 weeks corrected age requiring dual carriageway catheter
• After Failure or inability laying KTEC for children between 30 and 34 weeks of age corrected and heavy over 1000

Exclusion Criteria:

• Nouveau-né de poids < 1000g
• Nouveau-né de moins de 30 semaines d'âge corrigé
• Choix d'une autre voie d'abord plus judicieux (KTVO, KTC broviac)
• Sortie avant retrait du KTC

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
success rate without complications laying catheter ultrasound guided subclavian by supraclavicular route in newborn	1h after intervention

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Pierre Kuhn, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2015
• Primary Completion (Anticipated): October 14, 2017
• Study Completion (Anticipated): November 14, 2017

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Metabolic Diseases
• Other Study ID Numbers: 6287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No