LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

Study Overview
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Brief Summary
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Our study aimed to compare the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go.

Detailed Description
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LMA is an airway device frequently used in pediatric anesthesia. It is preferred for short interventions because it is less invasive compared to intubation. However, problems such as not being fully seated, slipping, and leakage can be encountered during placement. Multiple attempts after unsuccessful placement may cause undesirable results such as edema and sore throat. The aim in this study is to reveal the most accurate placement technique and to transfer this method to clinical applications. Our research is a prospective, randomized controlled method study. Patients will be divided into 3 groups. Group 1:(Standard technique) Group 2:(Placement with direct laryngoscopy) Group 3:(Placement with the aid of video laryngoscopy) After LMA Proseal placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.

Official Title
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Comparison of the Airway Sealing Pressures for Three Different Placement Techniques When Using Lma Proseal in Children

Conditions
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Anesthesia, Airway

Intervention / Treatment
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* Procedure: Group 1
* Procedure: Group 2
* Procedure: Group 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-10 years old Between 5-40 kg ASA (American Society of Anesthesiologists) physical score I/II Cases undergoing elective surgery lasting less than 90 minutes Exclusion Criteria: Patients who are expected to have a difficult airway Those with potential regurgitation risk (severe GER, presence of hiatal hernia) Those who will undergo head and neck surgery, laparoscopic surgery Those who will undergo surgery in the prone position Emergency surgical interventions Those who need muscle relaxants Presence of intraoral abscess, pharyngeal pathology Those who have had an upper or lower respiratory tract infection in the last 4 weeks History of allergy to the drugs to be used Failure of patients and their relatives to give consent

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Placement with standard technique | Procedure: Group 1<br>* The LMA Proseal will be inserted directly by hand, without the use of any laryngoscope, as recommended in the instruction manual. The cuff will be gently guided along the hard palate where it is pushed into the hypopharynx and increased resistance is felt, and the cuff will be placed towards the hypopharynx.<br>* Other names: Standard technique;|
| Active Comparator: Group 2<br>Placement with direct laryngoscopy | Procedure: Group 2<br>* Appropriately sized laryngoscope blade will be used and after the location of the epiglottis is determined, the tongue and epiglottis will be lifted forward. Then, LMA Proseal will be placed at the point where resistance is felt at a level where the proximal edge of the mask can be seen.<br>* Other names: Placement with direct laryngoscopy;|
| Active Comparator: Group 3<br>Placement with the aid of video laryngoscopy | Procedure: Group 3<br>* After the video laryngoscope is placed with an appropriately sized blade, the location of the epiglottis and vocal cords will be determined and the LMA Proseal will be placed at the point where slight resistance is encountered after the epiglottis is lifted. proximal aspect of LMA<br>* Other names: Placement with the aid of video laryngoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure | Oropharyngeal leak pressure (OLP) will be measured by closing the adjustable pressure limiting valve on the anesthesia machine. The fresh gas flow was adjusted to 3 L/min. When the APL (Adjustable pressure limiting) valve was closed and manually ventilated. The leak sound that occurs during ventilation will be auscultated. The first peak airway pressure at which the leak occurs will be recorded as the oropharyngeal leak pressure. After successful insertion, lma proseal location will be evaluated with fiberoptic imaging. | within 2-3 minutes after laryngeal mask insertion before start of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Measure heart rate in beats per minute by electrocardiography monitor. | Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. | 
| Peripheral oxygen saturation | Measure peripheral oxygen saturation per minute by pulse oximeter. | Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. | 
| Blood pressure | Measure blood pressure in millimeter of mercury by non-invasive blood pressure. | Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. | 
| İnsertion time | LMA insertion time (time from LMA handling to first wave formation in capnography) | intraoperative period | 
| Number of placement attempts | The number of attempts for optimal placement will be recorded | intraoperative period | 
| Need for optimization maneuvers | It will be recorded whether additional maneuvering is performed for optimal placement. LMA rotation, jaw thrust, head extension, and flexion will be use as optimization maneuvers. | intraoperative period | 
| Complications | İnvestigate the existence of complications that may be encountered in the routine after LMA placement and removal. | intraoperative and postoperative day 1. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraglottic airway device, pediatric population