Laryngeal Mask AirwayNCT02644226
Laryngeal Mask Airway (LMA) Complication in Children
An observational study of Laryngeal Mask Airway, run by Seoul National University Bundang Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- Sevoflurane and Desflurane
- How many people
- 3,528 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents
Who cannot join
- Tracheal intubation
About this study
Official title: 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.
Read the 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.
- Conditions
- Laryngeal Mask Airway
- Being tested
- Sevoflurane, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneOther
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.
DesfluraneOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sevoflurane | |
| 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. Receives: Other: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Laryngospasm
Measured: intraoperative
Occurrence of Cough
Measured: intraoperative
Occurrence of desaturation
Measured: intraoperative
Secondary outcomes (3)
Occurrence of Laryngospasm
Measured: through study completion, an average of 1 day
Occurrence of desaturation
Measured: through study completion, an average of 1 day
Occurrence of Cough
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AH-YOUNG OH, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644226
- Sponsor's protocol ID
- B-1407/258-117
- Status last verified
- May 2016
- First submitted
- 23 Dec 2015
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Investigation of Perioperative Upper Airway Complications After Anesthesia Using Supraglottic Airway Devices in Children: Comparison of Desflurane and Sevoflurane
- ClinicalTrials.gov ID
- NCT02644226
- Acronym / sponsor ID
- B-1407/258-117
- Conditions
- Laryngeal Mask Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,528 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | – | Other: SevofluraneThe 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 | – | Other: DesfluraneThe 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. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents
Key exclusion criteria (1 listed)
- Tracheal intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneThe 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. | Other | Sevoflurane |
| DesfluraneThe 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. | Other | Desflurane |
Primary outcome
Occurrence of Laryngospasm
Time frame: intraoperative
Occurrence of Cough
Time frame: intraoperative
Occurrence of desaturation
Time frame: intraoperative
3 secondary outcomes
Occurrence of Laryngospasm
Time frame: through study completion, an average of 1 day
Occurrence of desaturation
Time frame: through study completion, an average of 1 day
Occurrence of Cough
Time frame: through study completion, an average of 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Mask Airway, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Laryngospasm (time frame: intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.