Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

Not Applicable

• Conditions: Anesthesia Intubation Complication
• Interventions: Device: proseal laryngeal mask airway; Device: flexible laryngeal airway mask

• Registration Number: NCT04268043
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19
• Study Start: 2021-10-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Clinical diagnosis of otitis media.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
proseal laryngeal mask airway	proseal laryngeal mask airway	-
flexible laryngeal airway	flexible laryngeal airway mask	-

Primary Outcome Measures

Name	Time	Method
successful insert rate	0 minute after insertion	success rate of inserting laryngeal mask
tidal volume	5 minute afer successful insertion	tidal volume at 15cmH2O in patients with supine and lateral positioning
Number of Participants with cranial nerve injury	1hours after the surgery	Number of Participants with cranial nerve injury
leakage pressure	5 minute afer successful insertion	leakage pressure in patients with supine and lateral positioning
The scale of fiberoptic bronchoscopy	0 minute afer successful insertion	1 = only vocal cords visible; 2 = vocal cords plus posterior epiglottis visible; 3 = vocal cords plus anterior epiglottis visible; and 4 = vocal cords invisible

Secondary Outcome Measures

Name	Time	Method
Number of Participants with hoarseness	1hours after the surgery	Number of Participants with hoarseness
Number of Participants with laryngospasm	1hours after the surgery	Number of Participants with laryngospasm
Number of Participants with sore throat	1hours after the surgery	Number of Participants with sore throat
Number of Participants with cough	1hours after the surgery	Number of Participants with cough
Number of Participants with soft tissue injury	1hours after the surgery	Number of Participants with soft tissue injury