NCT02884895

Brief Summary

Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

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 Apr 2017

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

First Submitted

Initial submission to the registry

August 16, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

February 1, 2017

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

August 16, 2016

Last Update Submit

January 31, 2017

Conditions

Adverse Anesthesia Outcome

Keywords

Intubating Laryngeal Tube SuctionBlind intubation

Outcome Measures

Primary Outcomes (1)

  • Blind tracheal intubation time measure in seconds

    30 seconds

Secondary Outcomes (1)

  • Easy of insertion measure in numerical scale

    30 seconds

Study Arms (2)

Intubating laryngeal Tube Suction

EXPERIMENTAL

Intubating laryngeal Tube Suction

Device: Intubating Laryngeal Tube Suction

Direct Laryngoscopy

ACTIVE COMPARATOR

Direct Laryngoscopy

Device: Direct Laryngoscopy

Interventions

Intubating Laryngeal Tube SuctionDEVICE

Intubating Laryngeal Tube Suction Disposable

Intubating laryngeal Tube Suction
Direct LaryngoscopyDEVICE

Direct Laryngoscopy

Direct Laryngoscopy

Eligibility Criteria

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

You may qualify if:

  • American Society Anesthesiology class I and II

You may not qualify if:

  • Difficult airways
  • Cervical pathology
  • Full stomach

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
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 31, 2016

Study Start

April 1, 2017

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

February 1, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share