CClinicalTrials.gg
Status unknownNCT02884843Updated Aug 31, 2016

The New Intubating Laryngeal Tube Suction-Disposable

An interventional study of Intubation laryngeal Tube Suction and AuraGain Laryngeal Mask in Adverse Anesthesia Outcome, sponsored by Bnai Zion Medical Center. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-31.

Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D).

It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fibreoptic guidance. Similarly to the LTS-D, the iLTS-D also has a separate channel for gastric tubes placement up to a size of 18 Fr.

The current randomized study was designed to assess the success rate of blind and fibreoptic endotracheal intubation using iLTS-D, in comparison with the Ambu® AuraGain™ in adult patients under general anesthesia.

02

Conditions studied

  • Adverse Anesthesia Outcome

Keywords

  • Laryngeal Tube
  • blind intubation
  • fiberoptic
03

In context

Lead sponsor

Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society Anesthesiology I and II

Exclusion criteria

Exclusion Criteria:

  • Difficult intubation, cervical pathology
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Intubation laryngeal Tube Suction

    Intubation laryngeal Tube Suction Disposable

    Device: Intubation laryngeal Tube Suction

  • Active comparator
    AuraGain Laryngeal Mask

    AuraGain Laryngeal Mask

    Device: AuraGain Laryngeal Mask

Interventions

  • DeviceIntubation laryngeal Tube Suction

    Intubation laryngeal Tube Suction

  • DeviceAuraGain Laryngeal Mask

    AuraGain Laryngeal Mask

06

What researchers measure

Primary outcomes

  1. Time of blind intubation measure in seconds

    Time frame: 30 seconds

Secondary outcomes

  1. Time of Fiberoptic intubation measure in seconds

    Time frame: 60 seconds

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02884843
Lead sponsor
Bnai Zion Medical Center
Responsible party
LUIS.GAITINI (Medical Doctor, Bnai Zion Medical Center) — Principal investigator
First posted
Aug 31, 2016
Start date
Aug 2016
Primary completion
Aug 2016
Completion
Jul 2017 (estimated)
Last update
Aug 31, 2016

Study contacts

Luis A Gaitini, M.D.
Contact
luis.gaitini@b-zion.org.il
# 972 4 8359346
Mostafa Somri, M.D.
Contact
mostafa.somri@b-zion.org.il
# 972 4 8359304
Luis a Gaitini, M.D.
principal investigator · Bnai Zion Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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