Wireless US-guided CVC Placement in Infants

Performing Central Venous Catheters in Neonates and Small Infants Undergoing Cardiac Surgery Using a Wireless Transducer for Ultrasound Guidance: a Prospective, Observational Pilot Study

Background: Neonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing pediatric anesthesia and perioperative medicine. Aims: We here aimed to investigate the success rates in performing ultrasound guided central venous catheter insertion (CVC) in neonates and small infants undergoing cardiac surgery, and to evaluate the practicability and feasibility of thereby using a novel wireless ultrasound transducer (WUST).

Methods: Thirty neonates and small infants with a maximum body weight of 10 kg and need for CVC before cardiac surgery were included in this observational trial and were subdivided into two groups according to their weight: < 5 kg and ≥5 kg. Cannulation success, failure rate, essential procedure related time periods, and complications were recorded and the clinical utility of the WUST was assessed by a 5-point Likert scale.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter; Congenital Heart Disease in Children; Wireless Ultrasound
• Intervention / Treatment: Device: use of a wiresless US transducer

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

neonates and small infants with a maximum body weight of 10 kg and need for insertion of a CVC before cardiac surgery at our institution

Description

Inclusion Criteria:

neonates and small infants with a maximum body weight of 10 kg and need for insertion of a CVC before cardiac surgery at our institution

Exclusion Criteria:

• missing consent for study participation >10 kg body weight
• emergency surgery
• central venous catheter in situ

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of success using a wireless US for pediatric CVC	Clinical applicability of a wireless US transducer for CVC insertion for pediatric cardiac surgery	during cardiac surgery

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Judith Schiefer, MD, Ph, Medical University of Vienna

Publications and helpful links

General Publications

• Schiefer J, Lichtenegger P, Zimpfer D, Hutschala D, Kuessel L, Felli A, Hornykewycz S, Faybik P, Base E. Performing central venous catheters in neonates and small infants undergoing cardiac surgery using a wireless transducer for ultrasound guidance: a prospective, observational pilot study. BMC Pediatr. 2021 Aug 13;21(1):341. doi: 10.1186/s12887-021-02822-w.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 1386/2018

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