- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02711761
Ideal Depth of Guide Wire for Central Catheterization
Ideal Depth of Guide Wire for Right Internal Jugular Vein During Central Line Insertion
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Seoul, Korea, Republikken
- Seoul National University Boramae Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 15 cm
The depth of guide wire will be 15 cm from puncture site of skin prior to tissue dilation during central venous catheterization
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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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of arrhythmia
Tidsramme: during central venous catheterization
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during central venous catheterization
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Jung-Man Lee, M.D., Seoul National University Boramae Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 16-2015-105
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