Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy
NCT ID: NCT06356298
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2023-08-01
2023-12-31
Brief Summary
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Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .
The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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FLMA group
In the FLMA group, a FLMA was applied.
Airway Management: Flexible Reinforced Laryngeal Mask Airway
In the FLMA group, a FLMA was applied according to the manufacturer's recommendations. After lubrication of the posterior surface with oxybuprocaine hydrochloride gel, the FLMA was inserted after propping the shoulders. Its cuff was fully deflated before insertion, and the pressure was adjusted to 40 cm H2O with a manometer after insertion.
ETT group
In the ETT group, guided by a visual laryngoscope, a ETT was intubated.
Airway Management: Endotracheal Tube
In the ETT group, guided by a visual laryngoscope, a ETT was intubated after lubrication of the surface with oxybuprocaine hydrochloride gel: endotracheal tube size = (16+ age) /4. The cuff pressure of ETT was adjusted to 20 cm H2O with a handheld manometer after inflation.
Interventions
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Airway Management: Flexible Reinforced Laryngeal Mask Airway
In the FLMA group, a FLMA was applied according to the manufacturer's recommendations. After lubrication of the posterior surface with oxybuprocaine hydrochloride gel, the FLMA was inserted after propping the shoulders. Its cuff was fully deflated before insertion, and the pressure was adjusted to 40 cm H2O with a manometer after insertion.
Airway Management: Endotracheal Tube
In the ETT group, guided by a visual laryngoscope, a ETT was intubated after lubrication of the surface with oxybuprocaine hydrochloride gel: endotracheal tube size = (16+ age) /4. The cuff pressure of ETT was adjusted to 20 cm H2O with a handheld manometer after inflation.
Eligibility Criteria
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Inclusion Criteria
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* the oropharyngeal anatomy is normal
* competent to provide informed consent
Exclusion Criteria
* oropharyngeal anatomy is abnormal
* high risk of reflux aspiration
* liver or kidney failure
* psychiatric disorders
2 Years
10 Years
ALL
No
Sponsors
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Maternal and Child Health Hospital of Hubei Province
OTHER
Responsible Party
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Li Na
Deputy Chief Physician
Principal Investigators
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Na Li, MD
Role: PRINCIPAL_INVESTIGATOR
Maternal and Child Health Hospital of Hubei Province
Locations
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Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China
Countries
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Other Identifiers
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MCHH_004
Identifier Type: -
Identifier Source: org_study_id
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