Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03501602
Enrollment
80
Registered
2018-04-18
Start date
2018-04-05
Completion date
2019-07-05
Last updated
2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation;Difficult

Keywords

aintree, LMA protector; I-gel LMA, Fiberoptic Bronchoscope

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.

Interventions

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.

DEVICEI-gel LMA

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.

Sponsors

Kocaeli Derince Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Successful Tracheal IntubationUp to 10 minutesThis 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.

Secondary

MeasureTime frameDescription
Time to Placement of the Supra Glottic DeviceUp to 10 minutesThis 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
Time to Placement of the Aintree Airway Intubation CatheterUp to 10 minutesThis measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down
Laryngeal appearance stagingUp to 10 minutesStage 4: only the cords look Stage 3: cords + posterior epiglot seen Stage 2: cords + anterior epiglot seen Stage 1: no cords seen

Other

MeasureTime frameDescription
pre-induction oxygen saturationUp to 10 minutespre-induction oxygen saturation measurement
systolic and diastolic pulse after LMA insertionUp to 10 minutessystolic and diastolic pulse rate measurement after LMA insertion
heart rate after LMA insertionUp to 10 minutesheart rate measurement after LMA insertion
oxygen saturation after LMA insertionUp to 10 minutesoxygen saturation measurement after LMA insertion
Mouth opennessUp to 10 minutesmeasuring the maximum openness the patient can open his mouth
heart rate after after intubationUp to 10 minutesheart rate measurement after intubation
oxygen saturation after intubationUp to 10 minutesoxygen saturation measurement after intubation
end tidal carbon dioxide after LMA insertionUp to 10 minutesend tidal carbon dioxide measurement after LMA insertion
end tidal carbon dioxide after intubationUp to 10 minutesend tidal carbon dioxide measurement after intubation
systolic and diastolic pulse after intubationUp to 10 minutessystolic and diastolic pulse rate measurement after intubation
thiromental distanceUp to 10 minutesThe distance between the lowest end of the jaw and the thyroid overhang when the head is in full extension.
pre-induction systolic and diastolic pulseUp to 10 minutespre-induction systolic and diastolic pulse rate measurement
pre-induction heart rateUp to 10 minutespre-induction heart rate measurement

Countries

Turkey (Türkiye)

Contacts

Primary ContactAslı D Aydaş, Doctor
aduyguaydas@gmail.com+905058349312
Backup ContactKemal T Saraçoğlu, assoc. prof.
saracoglukt@gmail.com+905385478620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026