- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501602
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
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
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aslı D Aydaş, Doctor
- Phone Number: +905058349312
- Email: aduyguaydas@gmail.com
Study Contact Backup
- Name: Kemal T Saraçoğlu, assoc. prof.
- Phone Number: +905385478620
- Email: saracoglukt@gmail.com
Study Locations
-
-
Derince
-
Kocaeli, Derince, Turkey, 41900
- Recruiting
- Aslı Duygu Aydaş
-
Contact:
- Aslı D Aydaş
- Phone Number: +905058349312
- Email: aduyguaydas@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Investigators
- Study Chair: Kemal T Saraçoğlu, assoc. prof., Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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