Anesthesia Intubation Complication
Conditions
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.
Interventions
DEVICEflexible laryngeal airway mask
Ventilation with flexible laryngeal mask airway
Ventilation with proseal laryngeal mask airway
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of otitis media.
Exclusion criteria
Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with cranial nerve injury | 1hours after the surgery | Number of Participants with cranial nerve injury |
| tidal volume | 5 minute afer successful insertion | tidal volume at 15cmH2O in patients with supine and lateral positioning |
| successful insert rate | 0 minute after insertion | success rate of inserting laryngeal mask |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with sore throat | 1hours after the surgery | Number of Participants with sore throat |
| Number of Participants with hoarseness | 1hours after the surgery | Number of Participants with hoarseness |
| Number of Participants with cough | 1hours after the surgery | Number of Participants with cough |
| Number of Participants with laryngospasm | 1hours after the surgery | Number of Participants with laryngospasm |
| Number of Participants with soft tissue injury | 1hours after the surgery | Number of Participants with soft tissue injury |
Outcome results
None listed