NCT02339519

Brief Summary

This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic complications.

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 Jan 2015

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

January 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

January 3, 2015

Last Update Submit

December 7, 2015

Conditions

Airway Management

Keywords

Laryngeal Masks

Outcome Measures

Primary Outcomes (1)

  • Ease of insertion will be rated using a 4-point scale (4: success at the first attempt without tactile resistance; 3: success at the first attempt with tactile resistance; 2: success at the second attempt; 1: failure at the second attempt).

    1 month

Secondary Outcomes (4)

  • Composite measure of Hemodynamic parameters , change 20% from baseline in Mean Blood Pressure and Heart Rate

    baseline and 1 month

  • Number of Participants with oropharyngeal ( edema, haemorragie, blood in sputum) and systemic complications (anaflactic reactions)

    1 month

  • Time to successful insertion time and effective airway [ time to observation of 3 consequtive correct End-Tidal CO2 (EtCO2 )waves after insertion ] defined as insertion time and was recorded.

    1 monyh

  • Measure if the inserted device failed to provide adequate ventilation, the device position was changed within the oral cavity, which was then defined as repositioning

    1 month

Study Arms (3)

group LMA supreme

ACTIVE COMPARATOR

Patients who received Laryngeal Mask Airway; LMA supreme

Device: LMA SUPREME

group LMA classic

ACTIVE COMPARATOR

Patients who received Laryngeal Mask Airway; LMA classic

Device: LMA CLASSIC

group Fastrach

ACTIVE COMPARATOR

Patients who received Laryngeal Mask Airway; LMA fastrach

Device: LMA FASTRACH

Interventions

LMA CLASSICDEVICE

Classic LMA consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.

group LMA classic
LMA FASTRACHDEVICE

Fastrach LMA has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.

group Fastrach
LMA SUPREMEDEVICE

Supreme LMA is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner.

group LMA supreme

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normotensive patients with mouth aperture \> 3 cm,
  • thyromental distance \> 6 cm,
  • sternomental distance \> 12.5 cm,
  • body mass index \< 35 kg m-2 were included in the study.

You may not qualify if:

  • patients with ASA III-IV,
  • those with a history of gastroesophageal reflux,
  • pregnancy,
  • cardiovascular and central nerve system disease,
  • those with difficulty in cooperation,
  • those undergoing intracranial, intraabdominal and Ear-nose-throat surgeries were excluded from study.
  • None of the methods changed after commencement of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Umraniye Education and Research Hospital

Istanbul, Turkey, Turkey (Türkiye)

Location

Related Publications (2)

  • Timmermann A, Cremer S, Heuer J, Braun U, Graf BM, Russo SG. [Laryngeal mask LMA Supreme. Application by medical personnel inexperienced in airway management]. Anaesthesist. 2008 Oct;57(10):970-5. doi: 10.1007/s00101-008-1425-8. German.

    PMID: 18712321BACKGROUND

  • Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.

    PMID: 20540172BACKGROUND

Study Officials

  • Erdal Komur, MD

    Istanbul Umraniye Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 3, 2015

First Posted

January 15, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

TU(1)