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Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

NCT04268043 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-08-19

No results posted yet for this study

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.

Conditions

  • Anesthesia Intubation Complication

Interventions

DEVICE

flexible laryngeal airway mask

Ventilation with flexible laryngeal mask airway

DEVICE

proseal laryngeal mask airway

Ventilation with proseal laryngeal mask airway

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-06-01
Completion
2023-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04268043 on ClinicalTrials.gov