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OpenTrials
Completed

NCT Number: NCT04597021

Wireless US-guided CVC Placement in Infants

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.

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Key information

Conditions

Wireless Ultrasound Central Venous Catheter Congenital Heart Disease in Children

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of success using a wireless US for pediatric CVC

    Time frame: during cardiac surgery

    Clinical applicability of a wireless US transducer for CVC insertion for pediatric cardiac surgery

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2020
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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