Adverse Anesthesia OutcomeNCT02884843
The New Intubating Laryngeal Tube Suction-Disposable
A study testing Intubation laryngeal Tube Suction and AuraGain Laryngeal Mask in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- Intubation laryngeal Tube Suction and AuraGain Laryngeal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society Anesthesiology I and II
Who cannot join
- Difficult intubation, cervical pathology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Randomized Prospective Study Between the New Intubating Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Blind and Fibreoptic-guided Intubation
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.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Intubation laryngeal Tube Suction, AuraGain Laryngeal Mask
- Keywords
- Laryngeal Tube, blind intubation, fiberoptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation laryngeal Tube SuctionDevice
Intubation laryngeal Tube Suction
AuraGain Laryngeal MaskDevice
AuraGain Laryngeal Mask
| Study group | Role | What they receive |
|---|---|---|
| Intubation laryngeal Tube Suction | Active comparator | Intubation laryngeal Tube Suction Disposable Receives: Device: Intubation laryngeal Tube Suction |
| AuraGain Laryngeal Mask | Active comparator | AuraGain Laryngeal Mask Receives: Device: AuraGain Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of blind intubation measure in seconds
Measured: 30 seconds
Secondary outcomes (1)
Time of Fiberoptic intubation measure in seconds
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2016
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Anesthesia OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LUIS.GAITINI, Bnai Zion Medical Center
- Investigators
- Luis a Gaitini, M.D., Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884843
- Sponsor's protocol ID
- BnaiZionMC-16-LG-004
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Prospective Study Between the New Intubating Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Blind and Fibreoptic-guided Intubation
- ClinicalTrials.gov ID
- NCT02884843
- Acronym / sponsor ID
- BnaiZionMC-16-LG-004
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Laryngeal Tube, blind intubation, fiberoptic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Aug 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation laryngeal Tube Suction | Active comparator | Device: Intubation laryngeal Tube SuctionIntubation laryngeal Tube Suction Disposable |
| AuraGain Laryngeal Mask | Active comparator | Device: AuraGain Laryngeal MaskAuraGain Laryngeal Mask |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society Anesthesiology I and II
Key exclusion criteria (1 listed)
- Difficult intubation, cervical pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intubation laryngeal Tube SuctionIntubation laryngeal Tube Suction | Device | Intubation laryngeal Tube Suction |
| AuraGain Laryngeal MaskAuraGain Laryngeal Mask | Device | AuraGain Laryngeal Mask |
Primary outcome
Time of blind intubation measure in seconds
Time frame: 30 seconds
1 secondary outcome
Time of Fiberoptic intubation measure in seconds
Time frame: 60 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis a Gaitini, M.D. principal investigator
Bnai Zion Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Intubation laryngeal Tube Suction and AuraGain Laryngeal Mask in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis A Gaitini, M.D. (# 972 4 8359346, luis.gaitini@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of blind intubation measure in seconds (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.