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Fiberoptic Evaluation of the LMA(Laryngel Mask Airway) Position During Anesthesia With Spontaneous Respiration or Controlled Ventilation in Children

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ClinicalTrials.gov Identifier: NCT02220075
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of LMA insertion. When the investigators evaluate the LMA position, the investigators can use fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will bring high risk of aspiration. Recent studies reported the LMA position after general anesthesia induction not after operation. Therefore, the investigators will observe the LMA position three times; after general anesthesia induction, after caudal block, and after operation as well as the difference regarding to spontaneous and controlled ventilation.

Condition or disease
Pediatric Urologic Surgery

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Actual Study Start Date : March 4, 2015
Actual Primary Completion Date : April 3, 2015
Actual Study Completion Date : April 3, 2015

Group/Cohort
spontaneous group
maintain spontaneous breathing during the operation, and recording tidal volume, ET CO2, respiratory rate, peak airway pressure, SpO2
controlled group
controlled ventilation(tidal volume 8ml/kg, ET CO2 35~40mmHg) during the operation, recording peak airway pressure, SpO2



Primary Outcome Measures :
  1. sucess rate of LMA insertion [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. FOB(fiberoptic bronchoscope) grading of LMA position [ Time Frame: 1 hour ]
    Grade 1: only the larynx visible, Grade 2: larynz and epiglottis visible, Grade 3: epiglottis was impinging on the LMA grille, Grade 4: epiglottis was downfolded and the larynx could not be seen)



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Ages Eligible for Study:   1 Month to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients who are planed to get urologic surgery under general anesthesia using LMA
Criteria

Inclusion Criteria:

  1. ASA physical status 1 or 2,
  2. pediatric patients from 1month to 7 years old
  3. under general anesthesia using LMA
  4. getting informed consent from the guardian

Exclusion Criteria:

  1. difficult airway
  2. airway diseases ; URI, asthma, pneumonia
  3. not getting informed consent from the guardian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220075


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02220075     History of Changes
Other Study ID Numbers: 4-2013-0550
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: April 2018
Keywords provided by Yonsei University:
fiberoptic, LMA, caudal block