- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes of Ultrasound image of upper airway after Fiberoptic bronchoscopic grade of LMA insertion.
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 4-2011-0800
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infraumbilical Surgeries
-
University Hospitals Cleveland Medical CenterTerminatedLumbar Spine Surgeries | Cervical Spine SurgeriesUnited States
-
Assiut UniversityCompleted
-
Mansoura UniversityCompletedAbdominal SurgeriesEgypt
-
Mansoura UniversityUnknown
-
South Valley UniversityCompletedMajor Abdominal SurgeriesEgypt
-
Assiut UniversityUnknownMajor Abdominal SurgeriesEgypt
-
Yonsei UniversityCompleted
-
Ain Shams UniversityRecruiting
-
Assistance Publique Hopitaux De MarseilleRecruitingPlastic SurgeriesFrance
-
Derince Training and Research HospitalActive, not recruitingLaparoscopic SurgeriesTurkey
Clinical Trials on Ultrasound exam of upper airway
-
Assistance Publique - Hôpitaux de ParisActive, not recruiting
-
Samsung Medical CenterCompletedShoulder Arthroscopic SurgeryKorea, Republic of
-
Mongi Slim HospitalCompletedAirway Management | Upper Airway Sonographic EvaluationTunisia
-
University of Campania "Luigi Vanvitelli"Completed
-
GE HealthcareCompletedUltrasound Use in Emergency/Medical CareCanada
-
University Hospital, GrenobleInspire Medical Systems, Inc.RecruitingObstructive Sleep Apnea SyndromeFrance
-
Columbia UniversityNational Eye Institute (NEI)Completed
-
GE HealthcareCompletedUltrasound ExamsIndia
-
Loma Linda UniversityCompletedEndotracheal Tube Wrongly Placed During Anesthetic ProcedureUnited States
-
Technical University of MunichUniversity of Luebeck; Universitätsmedizin MannheimCompletedObstructive Sleep ApneaGermany