Heart DiseasesNCT02809664
Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way
An observational study of Heart Diseases and Diseases, Metabolic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn. Read more about this study
- Who is it for?
- Ages 43 to 44 weeks
- Conditions the study is for
- Heart Diseases, Diseases, Metabolic
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2015to 14 Nov 2017
- 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 43 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Patients hospitalized in the neonatal intensive care or neonatal intensive care. The 3 types of taken most often encountered load are: 1. support for prematurity at birth or poor adaptation at birth requiring intensive care or ventilatory support. 2. management of congenital heart diseases including ducto-dependent, awaiting surgery. 3. care for severe medical condition exposing one or more organ failure, between 0 and 28 days of life (severe infections, metabolic diseases, severe dehydration ...)
Who may be able to join
- Patient hospitalized in the neonatal intensive care or neonatal intensive care at the University Hospital of Hautepierre
- All infants less than 44 weeks corrected age who require a surgical approach
- In the first line if neonate over 34 weeks corrected age requiring dual carriageway catheter
- After Failure or inability laying KTEC for children between 30 and 34 weeks of age corrected and heavy over 1000
Who cannot join
- Nouveau-né de poids < 1000g
- Nouveau-né de moins de 30 semaines d'âge corrigé
- Choix d'une autre voie d'abord plus judicieux (KTVO, KTC broviac)
- Sortie avant retrait du KTC
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de réanimation néonatale - HOPITAL DE HAUTEPIERRE
Strasbourg, 67091
Pierre KUHN, MD, PhD, 33 3 88 12 77 79, Pierre.Kuhn@chru-strasbourg.fr
About this study
Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.
- Conditions
- Heart Diseases, Diseases, Metabolic
- Medical subject headings
- Heart Diseases, Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate without complications laying catheter ultrasound guided subclavian by supraclavicular route in newborn
Measured: 1h after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start14 Oct 2015
- Primary completion14 Oct 2017 (estimated)
- Study completion14 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Kuhn, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809664
- Sponsor's protocol ID
- 6287
- Status last verified
- May 2017
- First submitted
- 4 Jan 2016
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way
- ClinicalTrials.gov ID
- NCT02809664
- Acronym / sponsor ID
- 6287
- Conditions
- Heart Diseases, Diseases, Metabolic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Oct 2015 (actual)
- Primary completion
- 14 Oct 2017 (estimated)
- Study completion
- 14 Nov 2017 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- 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.
Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 43 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients hospitalized in the neonatal intensive care or neonatal intensive care. The 3 types of taken most often encountered load are: 1. support for prematurity at birth or poor adaptation at birth requiring intensive care or ventilatory support. 2. management of congenital heart diseases including ducto-dependent, awaiting surgery. 3. care for severe medical condition exposing one or more organ failure, between 0 and 28 days of life (severe infections, metabolic diseases, severe dehydration ...)
Key inclusion criteria (4 listed)
- Patient hospitalized in the neonatal intensive care or neonatal intensive care at the University Hospital of Hautepierre
- All infants less than 44 weeks corrected age who require a surgical approach
- In the first line if neonate over 34 weeks corrected age requiring dual carriageway catheter
- After Failure or inability laying KTEC for children between 30 and 34 weeks of age corrected and heavy over 1000
Key exclusion criteria (4 listed)
- Nouveau-né de poids < 1000g
- Nouveau-né de moins de 30 semaines d'âge corrigé
- Choix d'une autre voie d'abord plus judicieux (KTVO, KTC broviac)
- Sortie avant retrait du KTC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
success rate without complications laying catheter ultrasound guided subclavian by supraclavicular route in newborn
Time frame: 1h after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: No
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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.
Pierre Kuhn, MD principal investigator
University Hospital, Strasbourg, France
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 Heart Diseases and Diseases, Metabolic, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 May 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Kuhn, MD (33 3 88 12 77 86, Pierre.kuhn@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate without complications laying catheter ultrasound guided subclavian by supraclavicular route in newborn (time frame: 1h after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2017.