Adverse Anesthesia OutcomeNCT02884895
A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable
A study testing Intubating Laryngeal Tube Suction and Direct Laryngoscopy in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
Trial summary
Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many… 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?
- Intubating Laryngeal Tube Suction and Direct Laryngoscopy
- 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
- Apr 2017to Nov 2018
- 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 class I and II
Who cannot join
- Difficult airways
- Cervical pathology
- Full stomach
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Establishing a Definitive Airway: A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable
Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).
Read the detailed description
Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway.
Tracheal intubation is usually achieved by a direct laryngoscope. This method is taught both in the training of doctors and paramedics training. Although it is an effective method requires experience and skill demanding a long learning time The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Laryngeal Tube Suction and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.
The new generation of these devices allows perform blind intubation directly through a special channel. One of these devices is the Intubating Laryngeal Tube Suction
The aim of this study is to examine the effectiveness of the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).
The hypothesis is that definitive airway obtaining with Intubating Laryngeal Tube Suction will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Intubating Laryngeal Tube Suction, Direct Laryngoscopy
- Keywords
- Intubating Laryngeal Tube Suction, Blind 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 Disposable
Direct LaryngoscopyDevice
Direct Laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Intubating laryngeal Tube Suction | Experimental | Intubating laryngeal Tube Suction Receives: Device: Intubating Laryngeal Tube Suction |
| Direct Laryngoscopy | Active comparator | Direct Laryngoscopy Receives: Device: Direct Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blind tracheal intubation time measure in seconds
Measured: 30 seconds
Secondary outcomes (1)
Easy of insertion measure in numerical scale
Easy of insertion measure 1 to 5 Numerical scale
Measured: 30 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 startApr 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (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
- 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
- Investigators
- Luis A Gaitini, M.D., Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884895
- Sponsor's protocol ID
- BnaiZionMC-16-LG-007
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Definitive Airway: A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable
- ClinicalTrials.gov ID
- NCT02884895
- Acronym / sponsor ID
- BnaiZionMC-16-LG-007
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Intubating Laryngeal Tube Suction, Blind intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Apr 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (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.
Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).
Detailed description
Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway.
Tracheal intubation is usually achieved by a direct laryngoscope. This method is taught both in the training of doctors and paramedics training. Although it is an effective method requires experience and skill demanding a long learning time The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Laryngeal Tube Suction and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.
The new generation of these devices allows perform blind intubation directly through a special channel. One of these devices is the Intubating Laryngeal Tube Suction
The aim of this study is to examine the effectiveness of the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).
The hypothesis is that definitive airway obtaining with Intubating Laryngeal Tube Suction will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.
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 | Experimental | Device: Intubating Laryngeal Tube SuctionIntubating laryngeal Tube Suction |
| Direct Laryngoscopy | Active comparator | Device: Direct LaryngoscopyDirect Laryngoscopy |
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 class I and II
Key exclusion criteria (3 listed)
- Difficult airways
- Cervical pathology
- Full stomach
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 Disposable | Device | Intubating laryngeal Tube Suction |
| Direct LaryngoscopyDirect Laryngoscopy | Device | Direct Laryngoscopy |
Primary outcome
Blind tracheal intubation time measure in seconds
Time frame: 30 seconds
1 secondary outcome
Easy of insertion measure in numerical scale
Time frame: 30 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- 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 Intubating Laryngeal Tube Suction and Direct Laryngoscopy 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 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: status not confirmed, as of the sponsor's last update on 1 Feb 2017. 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?
Blind tracheal intubation time 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 1 Feb 2017.