Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia Intubation Complication

Intervention / Treatment
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* Device: flexible laryngeal airway mask
* Device: proseal laryngeal mask airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of otitis media. Exclusion Criteria: Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flexible laryngeal airway<br> | Device: flexible laryngeal airway mask<br>* Ventilation with flexible laryngeal mask airway<br>|
| Experimental: proseal laryngeal mask airway<br> | Device: proseal laryngeal mask airway<br>* Ventilation with proseal laryngeal mask airway<br>|

What is the study measuring?
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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 |