Comparison of Endotracheal Intubation Over the Aintree With Fiberoptic Bronchoskop Via the I-gel and LMA Protector

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Endotracheal Intubation Over the Aintree Catheter With Fiberoptic Bronchoskop Via the I-gel and Laryngeal Mask Airway Protector

Conditions
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Intubation;Difficult

Intervention / Treatment
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* Device: LMA protector
* Device: I-gel LMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be intubated in surgical operation requiring intubation over 18 years old Exclusion Criteria: Difficult intubation story Difficult intubation risk Presence of gastric reflux

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LMA protector group<br>The LMA Protector is a single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts | Device: LMA protector<br>* 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.<br>* Other names: aintree catheter, Fiberoptic brochoscop;|
| Active Comparator: I-gel LMA group<br>The I-gel is an alternative supraglottic device which provides the seal over the airway versus an inflatable cuff. | Device: I-gel LMA<br>* 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.<br>* Other names: aintree catheter, Fiberoptic brochoscop;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Up to 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aintree, LMA protector; I-gel LMA, Fiberoptic Bronchoscope