Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask

NCT04268043 | Unknown

• 1 other identifier: 2019041-2
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia Intubation Complication

Outcome Measures

Primary Outcomes (5)

• successful insert rate

  success rate of inserting laryngeal mask

  0 minute after insertion

• tidal volume

  tidal volume at 15cmH2O in patients with supine and lateral positioning

  5 minute afer successful insertion

• leakage pressure

  leakage pressure in patients with supine and lateral positioning

  5 minute afer successful insertion

• 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

• Number of Participants with cranial nerve injury

  Number of Participants with cranial nerve injury

  1hours after the surgery

Secondary Outcomes (5)

• Number of Participants with sore throat

  1hours after the surgery

• Number of Participants with hoarseness

  1hours after the surgery

• Number of Participants with cough

  1hours after the surgery

• Number of Participants with laryngospasm

  1hours after the surgery

• Number of Participants with soft tissue injury

  1hours after the surgery

Study Arms (2)

flexible laryngeal airway

EXPERIMENTAL

Device: flexible laryngeal airway mask

proseal laryngeal mask airway

EXPERIMENTAL

Device: proseal laryngeal mask airway

Interventions

flexible laryngeal airway mask DEVICE

Ventilation with flexible laryngeal mask airway

flexible laryngeal airway

proseal laryngeal mask airway DEVICE

Ventilation with proseal laryngeal mask airway

proseal laryngeal mask airway

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of otitis media.

You may not qualify if:

• Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: October 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08