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Completed

NCT Number: NCT06174896

LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

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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Key information

Conditions

Anesthesia Airway

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1

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.

Other names: Standard technique

Group 2

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.

Other names: Placement with direct laryngoscopy

Group 3

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

Other names: Placement with the aid of video laryngoscopy

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: within 2-3 minutes after laryngeal mask insertion before start of surgery

    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.

Secondary outcomes

  1. Blood pressure

    Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

    Measure blood pressure in millimeter of mercury by non-invasive blood pressure.

  2. İnsertion time

    Time frame: intraoperative period

    LMA insertion time (time from LMA handling to first wave formation in capnography)

  3. Number of placement attempts

    Time frame: intraoperative period

    The number of attempts for optimal placement will be recorded

  4. Need for optimization maneuvers

    Time frame: intraoperative period

    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.

  5. Complications

    Time frame: intraoperative and postoperative day 1.

    İnvestigate the existence of complications that may be encountered in the routine after LMA placement and removal.

  6. Heart rate

    Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

    Measure heart rate in beats per minute by electrocardiography monitor.

  7. Peripheral oxygen saturation

    Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

    Measure peripheral oxygen saturation per minute by pulse oximeter.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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