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

• ClinicalTrials.gov Identifier: NCT03501602
• Recruitment Status: Unknown
• First Posted: April 18, 2018
• Last Update Posted: April 19, 2018
• Sponsor: Kocaeli Derince Education and Research Hospital
• Information provided by (Responsible Party): Aslı duygu aydaş, Kocaeli Derince Education and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intubation;Difficult	Device: LMA protector; Device: I-gel LMA	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Comparison of Endotracheal Intubation Over the Aintree Catheter With Fiberoptic Bronchoskop Via the I-gel and Laryngeal Mask Airway Protector
• Actual Study Start Date: April 5, 2018
• Estimated Primary Completion Date: April 5, 2019
• Estimated Study Completion Date: July 5, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: LMA protector group; 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; 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.; Other Name: aintree catheter, Fiberoptic brochoscop
Active Comparator: I-gel LMA group; The I-gel is an alternative supraglottic device which provides the seal over the airway versus an inflatable cuff.	Device: 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.; Other Name: aintree catheter, Fiberoptic brochoscop

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Time to Placement of the Supra Glottic Device [ Time Frame: Up to 10 minutes ]
   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
2. Time to Placement of the Aintree Airway Intubation Catheter [ Time Frame: Up to 10 minutes ]
   This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down
3. Laryngeal appearance staging [ Time Frame: Up to 10 minutes ]
   Stage 4: only the cords look Stage 3: cords + posterior epiglot seen Stage 2: cords + anterior epiglot seen Stage 1: no cords seen

Other Outcome Measures:

1. Mouth openness [ Time Frame: Up to 10 minutes ]
   measuring the maximum openness the patient can open his mouth
2. thiromental distance [ Time Frame: Up to 10 minutes ]
   The distance between the lowest end of the jaw and the thyroid overhang when the head is in full extension.
3. pre-induction systolic and diastolic pulse [ Time Frame: Up to 10 minutes ]
   pre-induction systolic and diastolic pulse rate measurement
4. pre-induction heart rate [ Time Frame: Up to 10 minutes ]
   pre-induction heart rate measurement
5. pre-induction oxygen saturation [ Time Frame: Up to 10 minutes ]
   pre-induction oxygen saturation measurement
6. systolic and diastolic pulse after LMA insertion [ Time Frame: Up to 10 minutes ]
   systolic and diastolic pulse rate measurement after LMA insertion
7. heart rate after LMA insertion [ Time Frame: Up to 10 minutes ]
   heart rate measurement after LMA insertion
8. oxygen saturation after LMA insertion [ Time Frame: Up to 10 minutes ]
   oxygen saturation measurement after LMA insertion
9. systolic and diastolic pulse after intubation [ Time Frame: Up to 10 minutes ]
   systolic and diastolic pulse rate measurement after intubation
10. heart rate after after intubation [ Time Frame: Up to 10 minutes ]
    heart rate measurement after intubation
11. oxygen saturation after intubation [ Time Frame: Up to 10 minutes ]
    oxygen saturation measurement after intubation
12. end tidal carbon dioxide after LMA insertion [ Time Frame: Up to 10 minutes ]
    end tidal carbon dioxide measurement after LMA insertion
13. end tidal carbon dioxide after intubation [ Time Frame: Up to 10 minutes ]
    end tidal carbon dioxide measurement after intubation

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Aslı D Aydaş, Doctor; +905058349312; aduyguaydas@gmail.com

Contact: Kemal T Saraçoğlu, assoc. prof.; +905385478620; saracoglukt@gmail.com

Locations

Turkey

Aslı Duygu Aydaş; Recruiting

Kocaeli, Derince, Turkey, 41900

Contact: Aslı D Aydaş +905058349312 aduyguaydas@gmail.com

Sponsors and Collaborators

Kocaeli Derince Education and Research Hospital

Investigators

• Study Chair: Kemal T Saraçoğlu, assoc. prof.; Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi

More Information

• Responsible Party: Aslı duygu aydaş, specialist doctor, Kocaeli Derince Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT03501602
• Other Study ID Numbers: 2018/77
• First Posted: April 18, 2018
• Last Update Posted: April 19, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Aslı duygu aydaş, Kocaeli Derince Education and Research Hospital:

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