Comparation of Efficacy and Safety of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask in Otitis Media Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia Intubation Complication
- Sponsor
- Eye & ENT Hospital of Fudan University
- Enrollment
- 200
- Primary Endpoint
- successful insert rate
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of otitis media.
Exclusion Criteria
- •Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.
Outcomes
Primary Outcomes
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
Number of Participants with cranial nerve injury
Time Frame: 1hours after the surgery
Number of Participants with cranial nerve injury
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
Secondary Outcomes
- Number of Participants with hoarseness(1hours after the surgery)
- Number of Participants with laryngospasm(1hours after the surgery)
- Number of Participants with sore throat(1hours after the surgery)
- Number of Participants with cough(1hours after the surgery)
- Number of Participants with soft tissue injury(1hours after the surgery)