Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

Overview

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.

Full Title of Study: “Comparation of Efficacy and Safety of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask in Otitis Media Surgery”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Other
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: June 1, 2023

Interventions

• Device: flexible laryngeal airway mask
  • Ventilation with flexible laryngeal mask airway
• Device: proseal laryngeal mask airway
  • Ventilation with proseal laryngeal mask airway

Arms, Groups and Cohorts

• Experimental: flexible laryngeal airway
• Experimental: proseal laryngeal mask airway

Clinical Trial Outcome Measures

Primary Measures

• successful insert rate
  • Time Frame: 0 minute after insertion
  • success rate of inserting laryngeal mask
• tidal volume
  • Time Frame: 5 minute afer successful insertion
  • tidal volume at 15cmH2O in patients with supine and lateral positioning
• leakage pressure
  • Time Frame: 5 minute afer successful insertion
  • leakage pressure in patients with supine and lateral positioning
• The scale of fiberoptic bronchoscopy
  • Time Frame: 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
• Number of Participants with cranial nerve injury
  • Time Frame: 1hours after the surgery
  • Number of Participants with cranial nerve injury

Secondary Measures

• Number of Participants with sore throat
  • Time Frame: 1hours after the surgery
  • Number of Participants with sore throat
• Number of Participants with hoarseness
  • Time Frame: 1hours after the surgery
  • Number of Participants with hoarseness
• Number of Participants with cough
  • Time Frame: 1hours after the surgery
  • Number of Participants with cough
• Number of Participants with laryngospasm
  • Time Frame: 1hours after the surgery
  • Number of Participants with laryngospasm
• Number of Participants with soft tissue injury
  • Time Frame: 1hours after the surgery
  • Number of Participants with soft tissue injury

Participating in This Clinical Trial

Inclusion Criteria

Clinical diagnosis of otitis media. Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Eye & ENT Hospital of Fudan University
• Provider of Information About this Clinical Study
  • Sponsor