NCT02979171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

April 5, 2016

Last Update Submit

November 28, 2016

Conditions

Difficult Airway

Outcome Measures

Primary Outcomes (3)

  • 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

    score1-4 (easy to difficult)

    through study completion, an average of 6 months

Study Arms (3)

LMA-Classic

ACTIVE COMPARATOR

airway management with LMA-Classic

Device: Laryngeal Mask Airway Classic

LMA-Flexible

ACTIVE COMPARATOR

airway management with LMA-Flexible

Device: Laryngeal Mask Airway Classic

LMA-Proseal

ACTIVE COMPARATOR

airway management with LMA-Proseal

Device: Laryngeal Mask Airway Classic

Interventions

Laryngeal Mask Airway ClassicDEVICE
LMA-ClassicLMA-FlexibleLMA-Proseal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Science University

Istanbul, Şişli, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

December 1, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

TU(1)