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

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501602
• Other study ID #: 2018/77
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2018
• Last updated: April 17, 2018
• Start date: April 5, 2018
• Est. completion date: July 5, 2019

Study information

• Verified date: April 2018
• Source: Kocaeli Derince Education and Research Hospital
• Contact: Asli D Aydas, Doctor
• Phone: +905058349312
• Email: aduyguaydas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• LMA protector
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 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.

Locations

Country	Name	City	State
Turkey	Asli Duygu Aydas	Kocaeli	Derince

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli Derince Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mouth openness	measuring the maximum openness the patient can open his mouth	Up to 10 minutes
Other	thiromental distance	The distance between the lowest end of the jaw and the thyroid overhang when the head is in full extension.	Up to 10 minutes
Other	pre-induction systolic and diastolic pulse	pre-induction systolic and diastolic pulse rate measurement	Up to 10 minutes
Other	pre-induction heart rate	pre-induction heart rate measurement	Up to 10 minutes
Other	pre-induction oxygen saturation	pre-induction oxygen saturation measurement	Up to 10 minutes
Other	systolic and diastolic pulse after LMA insertion	systolic and diastolic pulse rate measurement after LMA insertion	Up to 10 minutes
Other	heart rate after LMA insertion	heart rate measurement after LMA insertion	Up to 10 minutes
Other	oxygen saturation after LMA insertion	oxygen saturation measurement after LMA insertion	Up to 10 minutes
Other	systolic and diastolic pulse after intubation	systolic and diastolic pulse rate measurement after intubation	Up to 10 minutes
Other	heart rate after after intubation	heart rate measurement after intubation	Up to 10 minutes
Other	oxygen saturation after intubation	oxygen saturation measurement after intubation	Up to 10 minutes
Other	end tidal carbon dioxide after LMA insertion	end tidal carbon dioxide measurement after LMA insertion	Up to 10 minutes
Other	end tidal carbon dioxide after intubation	end tidal carbon dioxide measurement after intubation	Up to 10 minutes
Primary	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	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
Secondary	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
Secondary	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