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

April 17, 2018 updated by: Aslı duygu aydaş, Kocaeli Derince Education and Research Hospital

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

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.

Study Overview

Status

Unknown

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Derince
      • Kocaeli, Derince, Turkey, 41900
        • Recruiting
        • Aslı Duygu Aydaş
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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 Names:
  • 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.
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 Names:
  • aintree catheter, Fiberoptic brochoscop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 10 minutes
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
Up to 10 minutes
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
Up to 10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mouth openness
Time Frame: Up to 10 minutes
measuring the maximum openness the patient can open his mouth
Up to 10 minutes
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.
Up to 10 minutes
pre-induction systolic and diastolic pulse
Time Frame: Up to 10 minutes
pre-induction systolic and diastolic pulse rate measurement
Up to 10 minutes
pre-induction heart rate
Time Frame: Up to 10 minutes
pre-induction heart rate measurement
Up to 10 minutes
pre-induction oxygen saturation
Time Frame: Up to 10 minutes
pre-induction oxygen saturation measurement
Up to 10 minutes
systolic and diastolic pulse after LMA insertion
Time Frame: Up to 10 minutes
systolic and diastolic pulse rate measurement after LMA insertion
Up to 10 minutes
heart rate after LMA insertion
Time Frame: Up to 10 minutes
heart rate measurement after LMA insertion
Up to 10 minutes
oxygen saturation after LMA insertion
Time Frame: Up to 10 minutes
oxygen saturation measurement after LMA insertion
Up to 10 minutes
systolic and diastolic pulse after intubation
Time Frame: Up to 10 minutes
systolic and diastolic pulse rate measurement after intubation
Up to 10 minutes
heart rate after after intubation
Time Frame: Up to 10 minutes
heart rate measurement after intubation
Up to 10 minutes
oxygen saturation after intubation
Time Frame: Up to 10 minutes
oxygen saturation measurement after intubation
Up to 10 minutes
end tidal carbon dioxide after LMA insertion
Time Frame: Up to 10 minutes
end tidal carbon dioxide measurement after LMA insertion
Up to 10 minutes
end tidal carbon dioxide after intubation
Time Frame: Up to 10 minutes
end tidal carbon dioxide measurement after intubation
Up to 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Anticipated)

April 5, 2019

Study Completion (Anticipated)

July 5, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2018/77

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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