LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Airway
• Intervention / Treatment: Procedure: Group 1; Procedure: Group 2; Procedure: Group 3

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey
    • Ondokuz Mayis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Placement with standard technique	Procedure: 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.; Other Names: Standard technique
Active Comparator: Group 2; Placement with direct laryngoscopy	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.; Other Names: Placement with direct laryngoscopy
Active Comparator: Group 3; Placement with the aid of video laryngoscopy	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; Other Names: Placement with the aid of video laryngoscopy

What is the study measuring?

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
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.
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.

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Study Director: Yasemin Burcu Üstün, Prof. Dr, Ondokuz Mayıs University

Publications and helpful links

General Publications

• Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z.
• Shyam T, Selvaraj V. Airway management using LMA-evaluation of three insertional techniques-a prospective randomised study. J Anaesthesiol Clin Pharmacol. 2021 Jan-Mar;37(1):108-113. doi: 10.4103/joacp.JOACP_60_19. Epub 2021 Apr 10.
• Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: October 14, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pediatric population; supraglottic airway device
• Other Study ID Numbers: LMAPR1955

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No