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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04268043
Other study ID # 2019041-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date December 1, 2023

Study information

Verified date August 2021
Source Eye & ENT Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Clinical diagnosis of otitis media. Exclusion Criteria: Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.

Study Design


Related Conditions & MeSH terms

  • Anesthesia Intubation Complication

Intervention

Device:
flexible laryngeal airway mask
Ventilation with flexible laryngeal mask airway
proseal laryngeal mask airway
Ventilation with proseal laryngeal mask airway

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eye & ENT Hospital of Fudan University

Outcome

Type Measure Description Time frame Safety issue
Primary successful insert rate success rate of inserting laryngeal mask 0 minute after insertion
Primary tidal volume tidal volume at 15cmH2O in patients with supine and lateral positioning 5 minute afer successful insertion
Primary leakage pressure leakage pressure in patients with supine and lateral positioning 5 minute afer successful insertion
Primary 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
Primary Number of Participants with cranial nerve injury Number of Participants with cranial nerve injury 1hours after the surgery
Secondary Number of Participants with sore throat Number of Participants with sore throat 1hours after the surgery
Secondary Number of Participants with hoarseness Number of Participants with hoarseness 1hours after the surgery
Secondary Number of Participants with cough Number of Participants with cough 1hours after the surgery
Secondary Number of Participants with laryngospasm Number of Participants with laryngospasm 1hours after the surgery
Secondary Number of Participants with soft tissue injury Number of Participants with soft tissue injury 1hours after the surgery
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