Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™

Phase 4

Completed

• Conditions: Difficult Airway
• Interventions: Device: Laryngeal Mask Airway Classic

• Registration Number: NCT02979171
• Lead Sponsor: Marmara University

Brief Summary

Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. In our study investigators aimed to determine which one will show the best performance with supraglottic airway means that LMA - Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created with attaching collar.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-05
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Study First Posted: 2016-12-01
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Without a history of difficult intubation, supine position, does not require tracheal intubation, undergo elective surgery

Exclusion Criteria

• High aspiration risk, who take more than 4 hours surgery
• Body mass index greater than of 35 kg/m²
• Disease related to the cervical spine
• The mouth opening is less than 20 mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LMA-Classic	Laryngeal Mask Airway Classic	airway management with LMA-Classic
LMA-Flexible	Laryngeal Mask Airway Classic	airway management with LMA-Flexible
LMA-Proseal	Laryngeal Mask Airway Classic	airway management with LMA-Proseal

Primary Outcome Measures

Name	Time	Method
insertion time and attempts in min.	through study completion, an average of 6 months
oropharyngeal leak pressure in cmH20.	through study completion, an average of 6 months
fiberoptic view grade by Brimacombe and Berry bronchoscopy score	through study completion, an average of 6 months	score1-4 (easy to difficult)

Trial Locations

Locations (1)

Istanbul Science University; 🇹🇷 Istanbul, Şişli, Turkey