- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03134560
Intravenous Cannulation Using Vein Display Instrument and Without Using Vein Display Instrument in Pediatric Patients
26. oktober 2017 opdateret af: Aries Perdana, Indonesia University
Comparison Between Using Vein Display Instrument and Without Using Vein Display Instrument for Successful Intravenous Cannulation in Pediatric Patients
This study aims to compare intravenous cannulation success rate between using vein display instrument and without using vein display instrument in pediatric patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study.
Parents' subjects were given informed consent before enrolling the study.
After doing asepsis and antisepsis procedure and putting on the tourniquet the first group would get intravenous cannulation without vein displaying instrument.
While for the second group, after doing asepsis procedure and tourniquet was put on, a vein display instrument was used to choose the vein.
Intravenous cannulation was done after antiseptic procedure.
After blood dripped out of the cannula, cannula was connected to the infusion set.
Evaluation was done to assess vein route establishment, canulation attempt number and swelling.
Data recorded were analyzed using Statistical Package for the Social Sciences (SPSS) using Chi-square test or Fisher Exact test.
Significant value is p<0.05.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
88
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Jakarta, Indonesien, 10430
- Cipto Mangunkusumo Central National Hospital
-
-
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 5 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects aged 0-5 years old
- Subjects with difficult vein access (e.g. edema, obesity, chemotherapy history),
- Subjects whose parents had signed the informed consent
- Subjects with available vein access locations at the back of either hands.
Exclusion Criteria:
- Subjects who had infection signs at the designated vein access location
- Subjects in need of emergency procedures.
Drop out Criteria:
- Subjects resigned from the study
- Subjects rejected any next attempt of intravenous cannulation
- Subjects who received anesthetic drugs before intravenous cannulation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: With vein display instrument
Vein cannulation was done after the vein display instrument displays the veins using infrared
|
|
|
Ingen indgriben: Without vein display instrument
vein cannulation was done without any vein display instrument
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful first vein cannulation attempt
Tidsramme: Day 1
|
Whether the first vein cannulation attempt successful or not will be recorded
|
Day 1
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Aries Perdana, Consultant, Indonesia University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.
- Kim MJ, Park JM, Rhee N, Je SM, Hong SH, Lee YM, Chung SP, Kim SH. Efficacy of VeinViewer in pediatric peripheral intravenous access: a randomized controlled trial. Eur J Pediatr. 2012 Jul;171(7):1121-5. doi: 10.1007/s00431-012-1713-9. Epub 2012 Mar 14.
- Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
- Kaddoum RN, Anghelescu DL, Parish ME, Wright BB, Trujillo L, Wu J, Wu Y, Burgoyne LL. A randomized controlled trial comparing the AccuVein AV300 device to standard insertion technique for intravenous cannulation of anesthetized children. Paediatr Anaesth. 2012 Sep;22(9):884-9. doi: 10.1111/j.1460-9592.2012.03896.x. Epub 2012 Jun 14.
- Chiao FB, Resta-Flarer F, Lesser J, Ng J, Ganz A, Pino-Luey D, Bennett H, Perkins C Jr, Witek B. Vein visualization: patient characteristic factors and efficacy of a new infrared vein finder technology. Br J Anaesth. 2013 Jun;110(6):966-71. doi: 10.1093/bja/aet003. Epub 2013 Feb 5.
- Myers LA, Arteaga GM, Kolb LJ, Lohse CM, Russi CS. Prehospital peripheral intravenous vascular access success rates in children. Prehosp Emerg Care. 2013 Oct-Dec;17(4):425-8. doi: 10.3109/10903127.2013.818180. Epub 2013 Aug 16.
- Scales K. Vascular access: a guide to peripheral venous cannulation. Nurs Stand. 2005 Aug 17-23;19(49):48-52. doi: 10.7748/ns2005.08.19.49.48.c3935.
- Simhi E, Kachko L, Bruckheimer E, Katz J. A vein entry indicator device for facilitating peripheral intravenous cannulation in children: a prospective, randomized, controlled trial. Anesth Analg. 2008 Nov;107(5):1531-5. doi: 10.1213/ane.0b013e318185cdab.
- Schindler E, Schears GJ, Hall SR, Yamamoto T. Ultrasound for vascular access in pediatric patients. Paediatr Anaesth. 2012 Oct;22(10):1002-7. doi: 10.1111/pan.12005.
- Donaldson JS. Pediatric vascular access. Pediatr Radiol. 2006 May;36(5):386-97. doi: 10.1007/s00247-006-0118-1. Epub 2006 Mar 15.
- de Negri DC, Avelar AF, Andreoni S, Pedreira Mda L. Predisposing factors for peripheral intravenous puncture failure in children. Rev Lat Am Enfermagem. 2012 Nov-Dec;20(6):1072-80. doi: 10.1590/s0104-11692012000600009. English, Portuguese, Spanish.
- Lamperti M, Pittiruti M. II. Difficult peripheral veins: turn on the lights. Br J Anaesth. 2013 Jun;110(6):888-91. doi: 10.1093/bja/aet078. No abstract available.
- John JM. Transillumination for vascular access: old concept, new technology. Paediatr Anaesth. 2007 Feb;17(2):197-8. doi: 10.1111/j.1460-9592.2006.02061.x. No abstract available.
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
1. april 2016
Primær færdiggørelse (Faktiske)
1. maj 2016
Studieafslutning (Faktiske)
1. maj 2016
Datoer for studieregistrering
Først indsendt
24. april 2017
Først indsendt, der opfyldte QC-kriterier
26. april 2017
Først opslået (Faktiske)
1. maj 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IndonesiaUAnes003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Studiedata/dokumenter
-
Lærebog
Oplysningskommentarer: Hannallah RS , Verghese ST. Peripheral vascular access. In: Bissonnette B, Anderson BJ, Bosenberg A, Engelhardt T, Mason LJ, Tobias JD, editors. Pediatric Anesthesia. Connecticut: People's Medical Publishing House USA, 2011.p. 1097-102.
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 .
Kliniske forsøg med Vanskelig vene adgang
-
Kafrelsheikh UniversityAktiv, ikke rekrutterendeÅreknuder i underekstremiteterne | Great Saphenous Vein (GSV) med venøs reflukssygdomEgypten
-
Medtronic EndovascularAfsluttetGreat Saphenous Vein (GSV) med venøs reflukssygdomForenede Stater
-
Medtronic EndovascularSapheon, Inc.AfsluttetGreat Saphenous Vein (GSV) med venøs reflukssygdomForenede Stater
-
Novartis PharmaceuticalsAfsluttetMakulaødem Sekundært til Branch Retinal Vein Oklusion (BRVO)Japan
-
Moscow City Hospital named after A.K. EramishantsevPirogov Russian National Research Medical University; Vishnevsky Center...AfsluttetÅreknuder | Venøs refluks | Kronisk venøs insufficiens (CVI) | Kronisk venøs lidelse | Great Saphenous Vein (GSV) med venøs reflukssygdomDen Russiske Føderation
Kliniske forsøg med Vein Display Instrument
-
Amplifi Vascular, Inc.AfsluttetEnd-stage nyresygdom, der kræver hæmodialyseParaguay
-
Argon Medical DevicesAfsluttetLeversygdomme | Karsygdomme | Portal hypertension | Ascites Hepatisk | HydrothoraxForenede Stater
-
Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; Shanxi Province... og andre samarbejdspartnereUkendt
-
Poitiers University HospitalAfsluttetRehabilitering | Knækirurgi | Point Light DisplayFrankrig
-
University Hospital, GrenobleTIMC-IMAG; Centre Medico Universitaire Daniel Douady (CMUDD)Afsluttet
-
Jamieson Bourque, MDAdvanced Medical Predictive Devices, Diagnostics and Displays, Inc.Aktiv, ikke rekrutterendeKlinisk forringelseForenede Stater
-
Centre Hospitalier Universitaire VaudoisUniversity of LausanneAfsluttetPost traumatisk stress syndrom | FødselsoplevelseSchweiz
-
Assiut UniversityIkke rekrutterer endnuLAD (Left Anterior Descending) Koronararteriestenose
-
Universidad Autonoma de Baja CaliforniaAfsluttetMedicinadhærens | Overholdelse af medicinMexico
-
Brigham and Women's HospitalAfsluttetSpinal hypotensionForenede Stater