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Clinical Trials/NCT04268043
NCT04268043
Unknown
Not Applicable

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

Eye & ENT Hospital of Fudan University0 sites200 target enrollmentOctober 1, 2021

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

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