- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01783366
Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Yangsan, Korea, Republiken av
- Rekrytering
- Pnuyh Anesthesia
-
Underutredare:
- JI WOOK YOON, PhD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- ASA physical status of I or II who were scheduled to undergo elective surgery of gastrointestinal tract with NGT insertion under general anesthesia were enrolled
Exclusion Criteria:
- Patients with maxillofacial trauma, inability to adequately protect airway, and esophageal abnormalities were excluded. Pregnant patients were also excluded from the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: CONTROL
In the control group (Group A) inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position.
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Aktiv komparator: tube-exchanger
The tube-exchanger group (Group B) made use of tube-exchanger G36402 (CAEC, [cook medical, Bloomington, IN]) as a stylet that was lubricated and inserted within 20-F NGT until the tip of the tube-exchanger was at the tip of the NGT
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of attempt of NGT insertion
Tidsram: after successful insertion of NGT, within 1 hr
|
After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion through the nostrils until 70cm of NGT was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. Total number of attempts until successful NGT insertion was recorded and tried at least three times, and was considered to have failed. Thus, procedure time would be the dependent factor of primary endpoin which could increse the success rate of NGT. |
after successful insertion of NGT, within 1 hr
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Procedure time of NGT insertion
Tidsram: after successful insertion of NGT, within 1 hr
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After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position.
The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT.
Success of appropriate NGT insertion was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT.
NGT insertion time recorded when the NGT begun to insert gently through the nostrils until 70cm of NGT.
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after successful insertion of NGT, within 1 hr
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view
Tidsram: after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours
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The investigators examined the occurrence of complication associated with NGT insertion.
After successful NGT insertion, we recorded presence of bleeding of the larynx, and knotting or kinking of NGT using laryngoscopy.
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after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours
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Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- PNU03-2013-002
- PNUYH03-2013-002 (Annan identifierare: PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL)
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