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

Difficult Airway Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979171
• Other study ID #: 71146310
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2016
• Last updated: November 28, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Difficult Airway

Intervention

Device:
• Laryngeal Mask Airway Classic

Locations

Country	Name	City	State
Turkey	Istanbul Science University	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insertion time and attempts in min.		through study completion, an average of 6 months	Yes
Primary	oropharyngeal leak pressure in cmH20.		through study completion, an average of 6 months	Yes
Primary	fiberoptic view grade by Brimacombe and Berry bronchoscopy score	score1-4 (easy to difficult)	through study completion, an average of 6 months	Yes