- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644226
Laryngeal Mask Airway (LMA) Complication in Children
May 17, 2016 updated by: AH-YOUNG OH, Seoul National University Bundang Hospital
Retrospective Investigation of Perioperative Upper Airway Complications After Anesthesia Using Supraglottic Airway Devices in Children: Comparison of Desflurane and Sevoflurane
Desflurane is known to be the most pungent of the currently used volatile anesthetics.
The investigators tried to find out if desflurane increases the incidence of perioperative upper airway complications in infants and children undergoing general anesthesia using supraglottic airways compared to sevoflurane.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents.
Study Type
Observational
Enrollment (Actual)
3528
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents in Seoul National University Bundang Hospital between June 2013 and June 2015.
Description
Inclusion Criteria:
- Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents
Exclusion Criteria:
- Tracheal intubation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sevoflurane
The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane as maintenance agents.
|
The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane as maintenance agents.
|
|
Desflurane
The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using desflurane as maintenance agents.
|
The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using desflurane as maintenance agents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Occurrence of Laryngospasm
Time Frame: intraoperative
|
intraoperative
|
|
Occurrence of Cough
Time Frame: intraoperative
|
intraoperative
|
|
Occurrence of desaturation
Time Frame: intraoperative
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Occurrence of Laryngospasm
Time Frame: through study completion, an average of 1 day
|
through study completion, an average of 1 day
|
|
Occurrence of desaturation
Time Frame: through study completion, an average of 1 day
|
through study completion, an average of 1 day
|
|
Occurrence of Cough
Time Frame: through study completion, an average of 1 day
|
through study completion, an average of 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
December 23, 2015
First Submitted That Met QC Criteria
December 29, 2015
First Posted (Estimate)
December 31, 2015
Study Record Updates
Last Update Posted (Estimate)
May 18, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1407/258-117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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