Intubation; DifficultNCT02878005
A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain
A study testing Intubating Laryngeal Tube Suction and Ambu AuraGain Laryngeal Mask in people with Intubation; Difficult, run by Bnai Zion Medical Center.
Trial summary
The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Intubating Laryngeal Tube Suction and Ambu 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
About this study
Official title: A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients
The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.
Read the detailed description
The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, 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 fiberoptic guidance. Similarly As in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr.
The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients 175patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5mm ETT and with a plastic stabilizer for removal of the device.
The current randomized study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under general anesthesia
- Conditions
- Intubation; Difficult
- Being tested
- Intubating Laryngeal Tube Suction, Ambu AuraGain Laryngeal Mask
- Keywords
- Intubating Laryngeal Tube, blind intubation, fiberoptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubating Laryngeal Tube SuctionDevice
Intubating Laryngeal Tube Suction
Ambu AuraGain Laryngeal MaskDevice
Ambu AuraGain Laryngeal Mask
| Study group | Role | What they receive |
|---|---|---|
| Intubating laryngeal Tube Suction | Active comparator | Intubating laryngeal Tube Suction Receives: Device: Intubating Laryngeal Tube Suction; Device: Ambu AuraGain Laryngeal Mask |
| Ambu AuraGain Laryngeal Mask | Active comparator | Ambu AuraGain Laryngeal Mask Receives: Device: Intubating Laryngeal Tube Suction; Device: Ambu AuraGain Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to performe blind intubation measure in second
Measured: 30 seconds
Secondary outcomes (1)
Time to performe fiberoptic intubation in second
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 posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies 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
- Treatment
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878005
- Sponsor's protocol ID
- BnaiZionMC-16-LG-005
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Somri M, Hochman O, Gaitini L, Hossein J, Gomez-Rios MA. The intubating laryngeal tube (iLTS-D) versus Ambu(R) Auragain as a conduit facilitating fiberoptic tracheal intubation in adult population: results from a prospective randomized controlled trial. Minerva Anestesiol. 2022 Dec;88(12):1074-1076. doi: 10.23736/S0375-9393.22.16731-3. No abstract available.
PubMed 36445250
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients
- ClinicalTrials.gov ID
- NCT02878005
- Acronym / sponsor ID
- BnaiZionMC-16-LG-005
- Conditions
- Intubation; Difficult
- Keywords
- Intubating 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 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 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 intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.
Detailed description
The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, 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 fiberoptic guidance. Similarly As in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr.
The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients 175patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5mm ETT and with a plastic stabilizer for removal of the device.
The current randomized study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under general anesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubating laryngeal Tube Suction | Active comparator | Device: Intubating Laryngeal Tube Suction, Device: Ambu AuraGain Laryngeal MaskIntubating laryngeal Tube Suction |
| Ambu AuraGain Laryngeal Mask | Active comparator | Device: Intubating Laryngeal Tube Suction, Device: Ambu AuraGain Laryngeal MaskAmbu AuraGain 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 |
|---|---|---|
| Intubating Laryngeal Tube SuctionIntubating Laryngeal Tube Suction | Device | Ambu AuraGain Laryngeal Mask, Intubating laryngeal Tube Suction |
| Ambu AuraGain Laryngeal MaskAmbu AuraGain Laryngeal Mask | Device | Ambu AuraGain Laryngeal Mask, Intubating laryngeal Tube Suction |
Primary outcome
Time to performe blind intubation measure in second
Time frame: 30 seconds
1 secondary outcome
Time to performe fiberoptic intubation in second
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 25 Aug 2016.
- Derived from this study: PubMed 36445250Somri M, Hochman O, Gaitini L, Hossein J, Gomez-Rios MA. The intubating laryngeal tube (iLTS-D) versus Ambu(R) Auragain as a conduit facilitating fiberoptic tracheal intubation in adult population: results from a prospective randomized controlled trial. Minerva Anestesiol. 2022 Dec;88(12):1074-1076. doi: 10.23736/S0375-9393.22.16731-3. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intubating Laryngeal Tube Suction and Ambu AuraGain Laryngeal Mask in people with Intubation; Difficult, 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 25 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to performe blind intubation measure in second (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878005, which also lists 1 linked publication.
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 25 Aug 2016.