Difficult IntubationNCT05347680
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 Difficult Intubation, run by Bnai Zion Medical Center at 1 site in Israel.
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 with fiberoptic guidance. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Difficult Intubation
- 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
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Sep 2019to 18 Jan 2021
- 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
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective and Randomized Study Comparing Fiberoptic Intubation Through the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients Secondary IDs:
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 with fiberoptic guidance. This study was designed to assess the Time 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 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 with fiberoptic guidance. This study was designed to assess the Time of 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) 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 height 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 7.5 mm ETT and with a plastic stabilizer for removal of the device.
The current randomized study was designed to assess the success rate fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under general anesthesia
- Conditions
- Difficult Intubation
- Being tested
- Intubating Laryngeal Tube Suction, Ambu AuraGain Laryngeal Mask
- Keywords
- fiberoptic, supraglottic, Laryngeal Tube, intubation
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 | Fiberoptic Intubation through intubating laryngeal Tube Suction Receives: Device: Intubating Laryngeal Tube Suction |
| Ambu AuraGain Laryngeal Mask | Active comparator | Fiberoptic Intubation through Ambu AuraGain Laryngeal Mask Receives: Device: Ambu AuraGain Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to perform fiberoptic intubation through supraglottic device in second
Time to perform endotracheal fiberoptic intubation through supraglottic device in second
Measured: 120 seconds
Secondary outcomes (1)
Success to obtain fiberoptic intubation through supraglottic device in second
Success to obtain endotracheal fiberoptic intubation through supraglottic device in second
Measured: 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start19 Sep 2019
- Primary completion15 Jan 2020
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Luis Gaitini, Prof, Principal investigator, Bani Zion Medical Center Haifa ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347680
- Sponsor's protocol ID
- 0132-16
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Randomized Study Comparing Fiberoptic Intubation Through the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients Secondary IDs:
- ClinicalTrials.gov ID
- NCT05347680
- Acronym / sponsor ID
- 0132-16
- Conditions
- Difficult Intubation
- Keywords
- fiberoptic, supraglottic, Laryngeal Tube, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 26 Apr 2022 (actual)
- 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 with fiberoptic guidance. This study was designed to assess the Time fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.
Detailed description
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 with fiberoptic guidance. This study was designed to assess the Time of 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) 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 height 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 7.5 mm ETT and with a plastic stabilizer for removal of the device.
The current randomized study was designed to assess the success rate 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 (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intubating laryngeal Tube Suction | Active comparator | Device: Intubating Laryngeal Tube SuctionFiberoptic Intubation through intubating laryngeal Tube Suction |
| Ambu AuraGain Laryngeal Mask | Active comparator | Device: Ambu AuraGain Laryngeal MaskFiberoptic Intubation through Ambu 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 (3 listed)
- Difficult intubation
- Cervical pathology
- pregnancy
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 | intubating laryngeal Tube Suction |
| Ambu AuraGain Laryngeal MaskAmbu AuraGain Laryngeal Mask | Device | Ambu AuraGain Laryngeal Mask |
Primary outcome
Time to perform fiberoptic intubation through supraglottic device in second
Time frame: 120 seconds
Time to perform endotracheal fiberoptic intubation through supraglottic device in second
1 secondary outcome
Success to obtain fiberoptic intubation through supraglottic device in second
Time frame: 120 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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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 Gaitini, Prof principal investigator
Bani Zion Medical Center Haifa ISRAEL
1 site in 1 country: see every site and its status.
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 Difficult Intubation, run by Bnai Zion Medical Center at 1 site in Israel.
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 3 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: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 perform fiberoptic intubation through supraglottic device in second (time frame: 120 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 26 Apr 2022.