LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2024-05-07

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.

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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.

Conditions

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Anesthesia Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)'.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1:1 ratio.

A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the methods which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.

Study Groups

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Group 1

Placement with standard technique

Group Type ACTIVE_COMPARATOR

Group 1

Intervention Type PROCEDURE

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.

Group 2

Placement with direct laryngoscopy

Group Type ACTIVE_COMPARATOR

Group 2

Intervention Type PROCEDURE

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.

Group 3

Placement with the aid of video laryngoscopy

Group Type ACTIVE_COMPARATOR

Group 3

Intervention Type PROCEDURE

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

Interventions

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Group 1

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.

Intervention Type PROCEDURE

Group 2

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.

Intervention Type PROCEDURE

Group 3

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

Intervention Type PROCEDURE

Other Intervention Names

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Standard technique Placement with direct laryngoscopy Placement with the aid of video laryngoscopy

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No