Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

Comparation of Efficacy and Safety of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask in Otitis Media Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia Intubation Complication
• Intervention / Treatment: Device: flexible laryngeal airway mask; Device: proseal laryngeal mask airway

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Clinical diagnosis of otitis media.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: flexible laryngeal airway	Device: flexible laryngeal airway mask; Ventilation with flexible laryngeal mask airway
Experimental: proseal laryngeal mask airway	Device: proseal laryngeal mask airway; Ventilation with proseal laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with sore throat	Number of Participants with sore throat	1hours after the surgery
Number of Participants with hoarseness	Number of Participants with hoarseness	1hours after the surgery
Number of Participants with cough	Number of Participants with cough	1hours after the surgery
Number of Participants with laryngospasm	Number of Participants with laryngospasm	1hours after the surgery
Number of Participants with soft tissue injury	Number of Participants with soft tissue injury	1hours after the surgery

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019041-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No