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- Essai clinique NCT01783366
Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Yangsan, Corée, République de
- Recrutement
- Pnuyh Anesthesia
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Sous-enquêteur:
- JI WOOK YOON, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: 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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Comparateur actif: 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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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of attempt of NGT insertion
Délai: 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 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PNU03-2013-002
- PNUYH03-2013-002 (Autre identifiant: PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL)
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