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

NCT03501602 | Unknown

• 1 other identifier: 2018/77
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation;Difficult

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Placement of the Supra Glottic Device

  Up to 10 minutes

• Time to Placement of the Aintree Airway Intubation Catheter

  Up to 10 minutes

• Laryngeal appearance staging

  Up to 10 minutes

Other Outcomes (13)

• Mouth openness

  Up to 10 minutes

• thiromental distance

  Up to 10 minutes

• pre-induction systolic and diastolic pulse

  Up to 10 minutes

Study Arms (2)

LMA protector group

ACTIVE COMPARATOR

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

I-gel LMA group

ACTIVE COMPARATOR

The I-gel is an alternative supraglottic device which provides the seal over the airway versus an inflatable cuff.

Device: I-gel LMA

Interventions

LMA protector DEVICE

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.

Also known as: aintree catheter, Fiberoptic brochoscop

LMA protector group

I-gel LMA DEVICE

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.

Also known as: aintree catheter, Fiberoptic brochoscop

I-gel LMA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be intubated in surgical operation requiring intubation
• over 18 years old

You may not qualify if:

• Difficult intubation story
• Difficult intubation risk
• Presence of gastric reflux

Sponsors & Collaborators

• Kocaeli Derince Education and Research Hospital: lead

Study Sites (1)

Aslı Duygu Aydaş

Kocaeli, Derince, 41900, Turkey (Türkiye)

RECRUITING

Study Officials

• Kemal T Saraçoğlu, assoc. prof.

  Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi

  STUDY CHAIR

Central Study Contacts

Aslı D Aydaş, Doctor

CONTACT

+905058349312; aduyguaydas@gmail.com

Kemal T Saraçoğlu, assoc. prof.

CONTACT

+905385478620; saracoglukt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: April 5, 2018
• Primary Completion: April 5, 2019
• Study Completion: July 5, 2019
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

TU (1)