Intubation;DifficultNCT03501602
Comparison of Endotracheal Intubation Over the Aintree With Fiberoptic Bronchoskop Via the I-gel and LMA Protector
A study testing LMA protector and I-gel LMA in people with Intubation;Difficult, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to compare the ease of use of the LMA protector and I-gel LMA for tracheal intubation with the Aintree catheter in our study. Laryngeal mask airway (LMA) protector is the second generation perilaryngeal seal type supraglottic airway tool. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- LMA protector and I-gel LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2018to 5 Jul 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be intubated in surgical operation requiring intubation
- over 18 years old
Who cannot join
- Difficult intubation story
- Difficult intubation risk
- Presence of gastric reflux
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aslı Duygu Aydaş
Kocaeli, Derince, 41900
Aslı D Aydaş, +905058349312, aduyguaydas@gmail.com
About this study
Official title: Comparison of Endotracheal Intubation Over the Aintree Catheter With Fiberoptic Bronchoskop Via the I-gel and Laryngeal Mask Airway Protector
Investigators aimed to compare the ease of use of the LMA protector and I-gel LMA for tracheal intubation with the Aintree catheter in our study.
Laryngeal mask airway (LMA) protector is the second generation perilaryngeal seal type supraglottic airway tool. The I-gel LMA is the second generation uncuffed supraglottic airway device. The Aintree Intubation Catheter has been designed for assisted fiberoptic intubation and for uncomplicated, atraumatic endotracheal tube exchange.Both LMA types have a structure that permits endotracheal intubation. In cases of difficult intubation, these two LMA types can be used. In the literature, there is no study comparing these two LMA types using Aintree catheter.Difficult Airway Society (DAS) published a guide for tracheal intubation in 2011 using Aintree. According to this guide, LMA type LMA Supreme is the most unfavorable for this process. However, there is no research or recommendation on the type of LMA most suitable for use in the literature. In accordance with the data of this study, it will be tried to show which LMA type may be suitable for intubation with Aintree catheter in patients.
Read the detailed description
Investigators will include adult patients over 18 years of age who will undergo a surgical operation requiring intubation. Patients will be divided into protector LMA and I-gel LMA groups by closed envelope method. Forty patients are planned for both groups. The age, weight, height, body mass index (BMI) of the patients, operation to be performed, ASA, mallampati, thyromental distance values will be recorded. A standard induction of anesthesia will be applied to the patient. After 2 minutes the LMA will be inserted. It will be recorded how many numbered LMAs are used, success rate, number of trials, optimization maneuver required. With LMA, whether sufficient amount of tidal volume can be given to the patient and whether sufficient amount of chest departure is observed during ventilation will be recorded together with tidal volume values. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Fiberoptic laryngeal appearance staging will be performed:
Stage 4: only the cords look Stage 3: cords + posterior epiglot seen Stage 2: cords + anterior epiglot seen Stage 1: no cords seen Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter in the appropriate size and the tube is placed in the trachea. Once participants have made sure that the tube is trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be coded. During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.
- Conditions
- Intubation;Difficult
- Being tested
- LMA protector, I-gel LMA
- Keywords
- aintree, LMA protector; I-gel LMA, Fiberoptic Bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA protectorDevice
Also called aintree catheter, Fiberoptic brochoscop
In this arm the LMA protector will be inserted. The time from took the LMA to placement of the LMA will be recorded. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After the insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter to the patient's trachea. Once you have made sure that the tube is in the trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be recorded.
I-gel LMADevice
Also called aintree catheter, Fiberoptic brochoscop
In this arm the I-gel LMA will be inserted. The time from took the LMA to placement of the LMA will be recorded. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After the insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter to the patient's trachea. Once you have made sure that the tube is in the trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| LMA protector group | Active comparator | The LMA Protector is a single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts Receives: Device: LMA protector |
| I-gel LMA group | Active comparator | The I-gel is an alternative supraglottic device which provides the seal over the airway versus an inflatable cuff. Receives: Device: I-gel LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful Tracheal Intubation
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
Measured: Up to 10 minutes
Secondary outcomes (3)
Time to Placement of the Supra Glottic Device
This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide
Measured: Up to 10 minutes
Time to Placement of the Aintree Airway Intubation Catheter
This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down
Measured: Up to 10 minutes
Laryngeal appearance staging
Stage 4: only the cords look Stage 3: cords + posterior epiglot seen Stage 2: cords + anterior epiglot seen Stage 1: no cords seen
Measured: Up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start5 Apr 2018
- Primary completion5 Apr 2019 (estimated)
- Study completion5 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı duygu aydaş, Kocaeli Derince Education and Research Hospital
- Investigators
- Kemal T Saraçoğlu, assoc. prof., Study chair, Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501602
- Sponsor's protocol ID
- 2018/77
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endotracheal Intubation Over the Aintree Catheter With Fiberoptic Bronchoskop Via the I-gel and Laryngeal Mask Airway Protector
- ClinicalTrials.gov ID
- NCT03501602
- Acronym / sponsor ID
- 2018/77
- Conditions
- Intubation;Difficult
- Keywords
- aintree, LMA protector; I-gel LMA, Fiberoptic Bronchoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 5 Apr 2019 (estimated)
- Study completion
- 5 Jul 2019 (estimated)
- First posted
- 18 Apr 2018 (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.
Investigators aimed to compare the ease of use of the LMA protector and I-gel LMA for tracheal intubation with the Aintree catheter in our study.
Laryngeal mask airway (LMA) protector is the second generation perilaryngeal seal type supraglottic airway tool. The I-gel LMA is the second generation uncuffed supraglottic airway device. The Aintree Intubation Catheter has been designed for assisted fiberoptic intubation and for uncomplicated, atraumatic endotracheal tube exchange.Both LMA types have a structure that permits endotracheal intubation. In cases of difficult intubation, these two LMA types can be used. In the literature, there is no study comparing these two LMA types using Aintree catheter.Difficult Airway Society (DAS) published a guide for tracheal intubation in 2011 using Aintree. According to this guide, LMA type LMA Supreme is the most unfavorable for this process. However, there is no research or recommendation on the type of LMA most suitable for use in the literature. In accordance with the data of this study, it will be tried to show which LMA type may be suitable for intubation with Aintree catheter in patients.
Detailed description
Investigators will include adult patients over 18 years of age who will undergo a surgical operation requiring intubation. Patients will be divided into protector LMA and I-gel LMA groups by closed envelope method. Forty patients are planned for both groups. The age, weight, height, body mass index (BMI) of the patients, operation to be performed, ASA, mallampati, thyromental distance values will be recorded. A standard induction of anesthesia will be applied to the patient. After 2 minutes the LMA will be inserted. It will be recorded how many numbered LMAs are used, success rate, number of trials, optimization maneuver required. With LMA, whether sufficient amount of tidal volume can be given to the patient and whether sufficient amount of chest departure is observed during ventilation will be recorded together with tidal volume values. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Fiberoptic laryngeal appearance staging will be performed:
Stage 4: only the cords look Stage 3: cords + posterior epiglot seen Stage 2: cords + anterior epiglot seen Stage 1: no cords seen Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter in the appropriate size and the tube is placed in the trachea. Once participants have made sure that the tube is trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be coded. During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA protector group | Active comparator | Device: LMA protectorThe LMA Protector is a single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts |
| I-gel LMA group | Active comparator | Device: I-gel LMAThe I-gel is an alternative supraglottic device which provides the seal over the airway versus an inflatable cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be intubated in surgical operation requiring intubation
- over 18 years old
Key exclusion criteria (3 listed)
- Difficult intubation story
- Difficult intubation risk
- Presence of gastric reflux
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 |
|---|---|---|
| LMA protectorAlso: aintree catheter, Fiberoptic brochoscopIn this arm the LMA protector will be inserted. The time from took the LMA to placement of the LMA will be recorded. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After the insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter to the patient's trachea. Once you have made sure that the tube is in the trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be recorded. | Device | LMA protector group |
| I-gel LMAAlso: aintree catheter, Fiberoptic brochoscopIn this arm the I-gel LMA will be inserted. The time from took the LMA to placement of the LMA will be recorded. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After the insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter to the patient's trachea. Once you have made sure that the tube is in the trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be recorded. | Device | I-gel LMA group |
Primary outcome
Time to Successful Tracheal Intubation
Time frame: Up to 10 minutes
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
3 secondary outcomes
Time to Placement of the Supra Glottic Device
Time frame: Up to 10 minutes
Time to Placement of the Aintree Airway Intubation Catheter
Time frame: Up to 10 minutes
Laryngeal appearance staging
Time frame: Up to 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Kemal T Saraçoğlu, assoc. prof. study chair
Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA protector and I-gel LMA in people with Intubation;Difficult, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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 19 Apr 2018. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aslı D Aydaş, Doctor (+905058349312, aduyguaydas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful Tracheal Intubation (time frame: Up to 10 minutes). 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 19 Apr 2018.