- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02711761
Ideal Depth of Guide Wire for Central Catheterization
Ideal Depth of Guide Wire for Right Internal Jugular Vein During Central Line Insertion
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Total of 69 ASA (American Society of Anesthesiologist) physical status class I or II patients will be enrolled.
Randomly assigned to three group according to the depth of guide-wire prior to tissue dilation during central catheterization via right internal jugular vein. (Group 1: 15 cm / Group 2: 17.5 cm / Group 3: 20 cm)
Central catheterization will be performed by anesthesiologists who be blinded to this study protocol.
An investigator will monitor and record whether any arrhythmia will occur.
The incidence of occurrence of arrhythmia will be compared between three groups.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Seoul, Korea, Republikken
- Seoul National University Boramae Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- patients receiving general anesthesia requiring central venous catheterization via right internal jugular vein.
- ASA (American Society of Anesthesiologist) physical status class I or II
Exclusion Criteria:
- at the pre-anesthetic evaluation, history of any arrhythmia
- when monitoring before the induction of anesthesia in the operating room, newly arrhythmia is observed.
- abnormal electrolyte at the pre-anesthetic evaluation
- too difficult to access right internal jugular vein for central catheterization (too short neck, infection at the site of right internal jugular vein, ventriculoperitoneal shunt or chemo-port existence at the site of right internal jugular vein. too close site to operating field)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 15 cm
The depth of guide wire will be 15 cm from puncture site of skin prior to tissue dilation during central venous catheterization
|
15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm. 17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm. 20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm. |
|
Eksperimentell: 17.5 cm
The depth of guide wire will be 17.5 cm from puncture site of skin prior to tissue dilation during central venous catheterization
|
15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm. 17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm. 20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm. |
|
Aktiv komparator: 20 cm
The depth of guide wire will be 20 cm from puncture site of skin prior to tissue dilation during central venous catheterization
|
15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm. 17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm. 20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of arrhythmia
Tidsramme: during central venous catheterization
|
during central venous catheterization
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Jung-Man Lee, M.D., Seoul National University Boramae Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 16-2015-105
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .