Evaluation of Electrocardiographic Guidance in Accurate Peripherally Inserted Central Catheter Placement in Children. (ECG-PICC)
21. juli 2022 opdateret af: Michael Agus, Boston Children's Hospital
This study will enroll up to 192 children less than 18 years of age, who will receive electrocardiographic guidance for placement of a PICC in addition to radiography done as standard care.
The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The placement of peripherally inserted central catheters (PICCs) is an important component of medical care for a variety of patients.
Current practice requires radiographic confirmation of catheter tip placement prior to use of the line for administration of medications.
Often the final catheter tip position may be uncertain based on radiographic imaging.
Other times, the catheter is malpositioned and requires adjustment and repeat radiographic imaging.
In adult patients, a system of confirmation that is based on electrocardiographic activity has been implemented and is FDA approved.
This study will enroll up to 192 children less than 18 years of age who will receive electrocardiographic guidance for placement of a PICC, in addition to radiography done as standard care.
The investigators will determine the location of the PICC tip from both ECG and radiograph, and then measure the degree of correlation between the two methods.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Boston Children's Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age from birth to 17 years in need of a PICC as part of the medical treatment plan
- Suitable for an upper extremity PICC placement
- Hemodynamically stable, including patients stable on vasopressors
Exclusion Criteria:
- Hemodynamic instability
- Cardiac abnormality which leads to abnormal p-wave on ECG
- Arrhythmia at baseline, documented duirng the current hospital admission
- Presence of pacemaker or pacing wires which are currently actively pacing
- Patients who have undergone reconstructive cardiac surgery and/or have anatomic variance that would affect the location of the sinoatrial node in relation to the superior vena cava
- Premature neonate (<37 weeks estimated gestational age)
- Placement of PICC in lower extremity
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Placement with C3 Wave Tip System
Subjects will have their central catheters placed with the addition of the FDA approved C3 Wave ECG-Based PICC Tip Confirmation System to the standard institution protocol.
The system will assist with location of the catheter tip in real-time, during the procedure.
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The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter.
This system includes an ECG monitor that will be connected to the guidewire used for catheter placement.
The changes in the ECG tracing will guide correct catheter placement.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)
Tidsramme: Less than 24 hours
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Successful placement (based upon review of chest radiograph) of the PICC as determined by the tip location of:
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Less than 24 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael SD Agus, MD, Boston Children's Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2016
Primær færdiggørelse (Faktiske)
1. december 2016
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
20. november 2014
Først indsendt, der opfyldte QC-kriterier
19. december 2014
Først opslået (Skøn)
24. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-P00015242
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
Will share with investigators based upon specific requests.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .