Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

Eye & ENT Hospital of Fudan University

Status: Unknown

Conditions: Anesthesia Intubation Complication

Treatments: Device: proseal laryngeal mask airway; Device: flexible laryngeal airway mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04268043

2019041-2

Details and patient eligibility

About

Objective To investigate the comparative effect of proseal laryngeal mask airway and flexible laryngeal airway mask during otitis media surgery. Methods 200 patients of ASA I or II classification, 18-65 years old, BMI<30 kg/m2 undergoing otitis media surgery are randomly divided into two groups (Group P with proseal laryngeal mask airway and Group F with flexible laryngeal airway mask, respectively). After induction, selecting a appropriate size of LMA to patient,s weight, using the standard index finger-guided technique inserting the LMA, and then the patients were ventilated mechanically. The success rate of inserting laryngeal mask, the intubation time, surgery time and wake time were also recorded. Tidal volume and leakage pressure in patients with supine and lateral positioning were assessed respectively. The scale of fiberoptic bronchoscopy was also recorded to show airway exposure. Related complications such as sore throat, hoarseness, cough, laryngospasm, bloating, nausea and vomiting, soft tissue injury, blood residue after pulling out the LMA were analyzed.Postoperative voice and laryngopharyngeal symptom are also recorded.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of otitis media.

Exclusion criteria

Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

flexible laryngeal airway

Experimental group

Treatment:

Device: flexible laryngeal airway mask

proseal laryngeal mask airway

Experimental group

Treatment:

Device: proseal laryngeal mask airway