LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06174896
• Other study ID #: LMAPR1955
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: April 29, 2024

Study information

• Verified date: April 2024
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 29, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway
• Anesthesia

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Insertion time	LMA insertion time (time from LMA handling to first wave formation in capnography)	intraoperative period
Secondary	Number of placement attempts	The number of attempts for optimal placement will be recorded	intraoperative period
Secondary	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
Secondary	Complications	Investigate the existence of complications that may be encountered in the routine after LMA placement and removal.	intraoperative and postoperative day 1.
Secondary	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.
Secondary	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.