NCT04618926

Brief Summary

Securing the airway is a pivotal skill for anesthesiologists and emergency care providers. Endotracheal intubation (ETI) is considered the gold standard for securing the airway. When ETI via laryngoscopy has failed, the use of a supraglottic airway device (SGAD) has been recommended. The intubating Laryngeal Tube Suction-Disposable and the LMA Protector are a new step in the evolution of supraglottic airways. Both SGADs are enable to ventilation and oxygenation, but the ventilation channel allow the insertion of an endotracheal tube and the use of fiberoptic bronchoscope. The aim of this study is to compare the time of fiberoptic intubation through the intubating Laryngeal Tube Suction Disposable and the LMA Protector in adult patients.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

November 2, 2020

Last Update Submit

February 7, 2021

Conditions

Keywords

iLTS-D, LMA Protector, Fiberoptic intubation

Outcome Measures

Primary Outcomes (1)

  • time of success fiberoptic endotracheal intubation

    seconds

    60 seconds

Study Arms (2)

intubating Laryngeal Tube Suction Disposable

intubating Laryngeal Tube Suction Disposable Airway control

Device: Device intubating Laryngeal Tube Suction Disposable

intubating laryngeal Tube suction Disposable

intubating laryngeal Tube Suction Disposable

Device: Device intubating Laryngeal Tube Suction Disposable

Interventions

Resuscitation in covid 19 patients

Also known as: Device LMA Protector
intubating Laryngeal Tube Suction Disposableintubating laryngeal Tube suction Disposable

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We will recruit patients if they are ≥18 years of age and of American Society of Anesthesiologists (ASA) physical status 1-2

You may qualify if:

  • Patients with normal airway
  • weight 50-90kg
  • AGE 18-75
  • ASA I-II

You may not qualify if:

  • predicted difficult airway
  • weight \> 90 Kg
  • aspiration risk
  • pregnancy woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mostafa Somri, M.D.

    Bnai Zion Medical Center Haifa Israel

    STUDY DIRECTOR

Central Study Contacts

Luis Gaitini, M.D.

CONTACT

Mostafa Somri, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor of Anesthesiology

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 6, 2020

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

December 31, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02