Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

Anesthesia Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04268043
• Other study ID #: 2019041-2
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

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