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NCT04597021 Clinical Trial

Wireless US-guided CVC Placement in Infants

Congenital Heart Disease in Children Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04597021
Other study ID # 1386/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date January 30, 2019

Study information
Verified date October 2020
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers
Gender All
Age group N/A to 2 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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