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Clinical Trials/NCT02979171
NCT02979171CompletedPhase 4

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

Marmara University1 site in 1 country90 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
90
Locations
1
Primary Endpoint
insertion time and attempts in min.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

LMA-Classic

Active Comparator

airway management with LMA-Classic

Intervention: Laryngeal Mask Airway Classic (Device)

LMA-Flexible

Active Comparator

airway management with LMA-Flexible

Intervention: Laryngeal Mask Airway Classic (Device)

LMA-Proseal

Active Comparator

airway management with LMA-Proseal

Intervention: Laryngeal Mask Airway Classic (Device)

Outcomes

Primary Outcomes

insertion time and attempts in min.

Time Frame: through study completion, an average of 6 months

oropharyngeal leak pressure in cmH20.

Time Frame: through study completion, an average of 6 months

fiberoptic view grade by Brimacombe and Berry bronchoscopy score

Time Frame: through study completion, an average of 6 months

score1-4 (easy to difficult)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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