NCT02884843

Brief Summary

The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in blind and fibreoptic endotracheal intubation. The current randomized study is designed to assess the success rate of blind and fibreoptic endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite differences in their structural design.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Status
unknown

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

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 15, 2016

Last Update Submit

August 30, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

Laryngeal Tubeblind intubationfiberoptic

Outcome Measures

Primary Outcomes (1)

  • Time of blind intubation measure in seconds

    30 seconds

Secondary Outcomes (1)

  • Time of Fiberoptic intubation measure in seconds

    60 seconds

Study Arms (2)

Intubation laryngeal Tube Suction

ACTIVE COMPARATOR

Intubation laryngeal Tube Suction Disposable

Device: Intubation laryngeal Tube Suction

AuraGain Laryngeal Mask

ACTIVE COMPARATOR

AuraGain Laryngeal Mask

Device: AuraGain Laryngeal Mask

Interventions

Intubation laryngeal Tube SuctionDEVICE

Intubation laryngeal Tube Suction

Intubation laryngeal Tube Suction
AuraGain Laryngeal MaskDEVICE

AuraGain Laryngeal Mask

AuraGain Laryngeal Mask

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society Anesthesiology I and II

You may not qualify if:

  • Difficult intubation, cervical pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Luis a Gaitini, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis A Gaitini, M.D.

CONTACT

# 972 4 8359346luis.gaitini@b-zion.org.il

Mostafa Somri, M.D.

CONTACT

# 972 4 8359304mostafa.somri@b-zion.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 31, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2016

Study Completion

July 1, 2017

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share