- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02165319
The Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change (LateralCuff)
Comparison of the Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change: Barrel-shaped vs. Taper-shaped Cuff
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The position of endotracheal tubes depends on the position of the patients. The change of the tube's position is known to influence the pressure of tube's cuff. The shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force.
The investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Seoul, Korea, Republikken
- Seoul National University 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:
- Patient scheduled for nephrectomy in lateral decubitus position
Exclusion Criteria:
- Pregnancy
- Patients with difficult airway
- Patients with neck motion disorder
- Patients with history of neck surgery
- Patients with history of oral and pharyngeal surgery
- Patients with body mass index > 35
- Patients without teeth
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Barrel
Endotracheal tube with barrel-shaped cuff will be used during general anesthesia.
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Barrel-shaped endotracheal tube will be used during general anesthesia.
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Aktiv komparator: Tapered
Endotracheal tube with tapered-shaped cuff will be used during general anesthesia.
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Tapered-shaped tube will be used during general anesthesia.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The cuff pressure after supine-to-lateral position change
Tidsramme: At 10 minutes after anesthetic induction
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The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®.
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At 10 minutes after anesthetic induction
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The distance from the tube to the carina
Tidsramme: At 10 minutes after anesthetic induction
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The distance from the tube to the carina will be measured using bronchoscopy after supine-to-lateral position change.
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At 10 minutes after anesthetic induction
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Complications related to endotracheal tube
Tidsramme: At 0, 2, and 24 hours postoperatively
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Complications related to endotracheal tube (sore throat, hoarseness, dysphagia and cough) will be measured as 0:none, 1:mild, 2:moderate, 3:severe at 0, 2, and 24 hours postoperatively.
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At 0, 2, and 24 hours postoperatively
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Hee-Pyoung Park, PhD, Seoul National University of Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LateralTaperedCuff-phpkhc
- LateralCuff_SNUH
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