Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy

Maternal and Child Health Hospital of Hubei Province

Status and phase: Completed; Phase 2

Conditions: Adenotonsillectomy; Airway; Anesthesia Intubation Complication; Children

Treatments: Other: Airway Management: Endotracheal Tube; Other: Airway Management: Flexible Reinforced Laryngeal Mask Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT06356298

MCHH_004

Details and patient eligibility

About

The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.

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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who choose to have adenotonsillectomy surgery
• the American Society of Anesthesiologists (ASA) physical status ranked I-II
• the oropharyngeal anatomy is normal
• competent to provide informed consent

Exclusion criteria

• upper respiratory tract infection one week before surgery
• oropharyngeal anatomy is abnormal
• high risk of reflux aspiration
• liver or kidney failure
• psychiatric disorders

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

FLMA group

Experimental group

Description:

In the FLMA group, a FLMA was applied.

Treatment:

Other: Airway Management: Flexible Reinforced Laryngeal Mask Airway

ETT group

Experimental group

Description:

In the ETT group, guided by a visual laryngoscope, a ETT was intubated.

Treatment:

Other: Airway Management: Endotracheal Tube