Wireless US-guided CVC Placement in Infants

NCT04597021 | Completed

• 1 other identifier: 1386/2018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wireless Ultrasound; Central Venous Catheter; Congenital Heart Disease in Children

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

use of a wiresless US transducer DEVICE

to (evaluate the practicability of applying a wireless US transducer for central venous catheter-placement in these patients.

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 34389009 DERIVED

Study Officials

• Judith Schiefer, MD, Ph

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD.

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: August 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)