Clinical trial NCT03501602: Comparison of Endotracheal Intubation Over the Aintree With Fiberoptic Bronchoskop Via the I-gel and LMA Protector
Official title: Comparison of Endotracheal Intubation Over the Aintree Catheter With Fiberoptic Bronchoskop Via the I-gel and Laryngeal Mask Airway Protector
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation;Difficult
Keywords: aintree, LMA protector; I-gel LMA, Fiberoptic Bronchoscope
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Successful Tracheal Intubation
timeFrame: Up to 10 minutes
Secondary outcomes:
measure: Time to Placement of the Supra Glottic Device
timeFrame: Up to 10 minutes
measure: Time to Placement of the Aintree Airway Intubation Catheter
timeFrame: Up to 10 minutes
measure: Laryngeal appearance staging
timeFrame: Up to 10 minutes
Other outcomes:
measure: Mouth openness
timeFrame: Up to 10 minutes
measure: thiromental distance
timeFrame: Up to 10 minutes
measure: pre-induction systolic and diastolic pulse
timeFrame: Up to 10 minutes
measure: pre-induction heart rate
timeFrame: Up to 10 minutes
measure: pre-induction oxygen saturation
timeFrame: Up to 10 minutes
measure: systolic and diastolic pulse after LMA insertion
timeFrame: Up to 10 minutes
measure: heart rate after LMA insertion
timeFrame: Up to 10 minutes
measure: oxygen saturation after LMA insertion
timeFrame: Up to 10 minutes
measure: systolic and diastolic pulse after intubation
timeFrame: Up to 10 minutes
measure: heart rate after after intubation
timeFrame: Up to 10 minutes
measure: oxygen saturation after intubation
timeFrame: Up to 10 minutes
measure: end tidal carbon dioxide after LMA insertion
timeFrame: Up to 10 minutes
measure: end tidal carbon dioxide after intubation
timeFrame: Up to 10 minutes
Locations:
city: Kocaeli
country: Turkey
facility: Aslı Duygu Aydaş
state: Derince
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
name: Kemal T Saraçoğlu, assoc. prof.
role: STUDY_CHAIR
References: