Wireless UltrasoundNCT04597021
Wireless US-guided CVC Placement in Infants
An observational study of Wireless Ultrasound and Central Venous Catheter, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: Neonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing pediatric anesthesia and perioperative medicine. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Wireless Ultrasound, Central Venous Catheter, Congenital Heart Disease in Children
- What is being tested?
- use of a wiresless US transducer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2018to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Child
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
Who may be able to join
- 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
Who cannot join
- missing consent for study participation >10 kg body weight
- emergency surgery
- central venous catheter in situ
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- use of a wiresless US transducer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of a wiresless US transducerDevice
to (evaluate the practicability of applying a wireless US transducer for central venous catheter-placement in these patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of success using a wireless US for pediatric CVC
Clinical applicability of a wireless US transducer for CVC insertion for pediatric cardiac surgery
Measured: during cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Aug 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wireless UltrasoundStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Schiefer, Medical University of Vienna
- Investigators
- Judith Schiefer, MD, Ph, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597021
- Sponsor's protocol ID
- 1386/2018
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34389009
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04597021
- Acronym / sponsor ID
- 1386/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- missing consent for study participation >10 kg body weight
- emergency surgery
- central venous catheter in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of a wiresless US transducerto (evaluate the practicability of applying a wireless US transducer for central venous catheter-placement in these patients. | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 34389009Schiefer 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.
- Individual participant dataSharing planned: No
Related trials for Wireless Ultrasound
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Pregnant Woman With Single Pregnancy, Ultrasound Fetal Medicine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Schiefer, MD, Ph principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wireless Ultrasound and Central Venous Catheter, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of success using a wireless US for pediatric CVC (time frame: during cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04597021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.