Wireless US-guided CVC Placement in Infants

Completed

• Conditions: Congenital Heart Disease in Children; Wireless Ultrasound; Central Venous Catheter

• Registration Number: NCT04597021
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of success using a wireless US for pediatric CVC	during cardiac surgery	Clinical applicability of a wireless US transducer for CVC insertion for pediatric cardiac surgery

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria