- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01655459
Evaluation of the LMA Position Using Ultrasound in Pediatric Patients
Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA position, but the rotated degree of LMA was not considered in that grading. We hypothesized that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be detected on ultrasound. This study was designed to assess the predictability of the rotated LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.
Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to this study. Ultrasound was performed on supraglottic and vocal cords area before and after LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade >3 was showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre- and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of rotation were measured.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Aged 1 ms - 6 years,
- undergoing infraumbilical surgery
Exclusion Criteria:
- coagulopathy
- pathologic lesions on neck or upper airway
- mallampati class III or IV
- difficult airway past history
- high risk group of aspiration pneumonitis
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Ultrasound exam of upper airway
Following Internal Review Board approval(4-2011-0800) and written informed consent, total 100 patients(ASA I and II children aged 1 month to 6years) undergoing infra-umblicular urologic surgeries were included in the study.
Children with upper respiratory tract infection, restricted mouth opening, congenital heart disease and those at risk for aspiration were excluded.
|
LMA-position was evaluated with fiberoptic laryngoscopy.
The ultrasound findings of pre- and post-LMA were compared.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
changes of Ultrasound image of upper airway after Fiberoptic bronchoscopic grade of LMA insertion.
Zeitfenster: After the induction of general anesthesia, ultasound image was gained before and after the LMA insertion. Fiberoptic bronchoscpy was done after the LMA insertion.
|
After the induction of general anesthesia, ultasound image was gained before and after the LMA insertion. Fiberoptic bronchoscpy was done after the LMA insertion.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 4-2011-0800
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Ultrasound exam of upper airway
-
Medical Corps, Israel Defense ForceRekrutierungTrauma-Verletzung | BlutungswundeIsrael
-
Connolly Hospital BlanchardstownRoyal College of Surgeons, Ireland; European Society for Trauma and Emergency... und andere MitarbeiterAbgeschlossenDivertikulitis, Dickdarm | Gallenkrankheit | Gallenstein; Cholezystitis, akut | Abszess BeckenIrland, Italien, Portugal, Spanien