Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

NCT ID: NCT04268043

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-12-01

Brief Summary

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.

Conditions

Anesthesia Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

flexible laryngeal airway

Group Type: EXPERIMENTAL

flexible laryngeal airway mask

Intervention Type: DEVICE

Ventilation with flexible laryngeal mask airway

proseal laryngeal mask airway

Group Type: EXPERIMENTAL

proseal laryngeal mask airway

Intervention Type: DEVICE

Ventilation with proseal laryngeal mask airway

Interventions

flexible laryngeal airway mask

Ventilation with flexible laryngeal mask airway

Intervention Type: DEVICE

proseal laryngeal mask airway

Ventilation with proseal laryngeal mask airway

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of otitis media.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2019041-2

Identifier Type: -

Identifier Source: org_study_id