NCT05503277

A RANDOMIZED CONTROLED TRAIL COMARING LARYNGEAL TUBE SUCTION DISPOSABLE AND I-gel IN PEDIATRIC PATIENT

Status unknown NA Last updated 16 August 2022

What this trial tests

NA trial testing LTSD in Seal Pressure in 100 participants. Status unknown.

Timeline

1 November 2022

Primary endpoint
1 November 2023

31 December 2023

Quick facts

Lead sponsor	Bnai Zion Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	100
Start date	1 November 2022
Primary completion	1 November 2023
Estimated completion	31 December 2023

Drugs / interventions tested

• LTSD
• i-gel

Conditions studied

• Seal Pressure — all drugs for Seal Pressure →

Sponsor

Bnai Zion Medical Center

Who can join

Adults 2 to 10, any sex, with Seal Pressure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction The Laryngeal Tube Suction Disposable LTS-D and the i-gel are a second generation supraglottic airway device SAD, the devices have a drain tube to allow access to the gastrointestinal.

The i-gel is a second generation SAD. Does not need an inflatable cuff because the thermoplastic elastomer provides the seal.

The study designs to compare the Oropharyngeal leak pressure (OLP) of LTS-D with the i-gel that allow the use of Pressure Control Ventilation.

Materials and methods Approval obtained from the institute Ethics Committee, No 0117-22-BNZ. Written parental consent will be obtained Hundred children (50 patients in each device of both sex, weighing 10-35 kg, with an ASA physical status I, scheduled for elective minor surgery Study design Devices are the pediatric LTS-D and the i-gel. The patients will fast for 6 h for solids and 2 h for clear fluids and will be unpremeditated, anesthesia will initiate following a standardized protocol.

Both devices will be inserted blindly by expert pediatric anesthesiologists. Leak pressure, will be determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l min-1. The airway pressure at which an equilibrium is reached will be noted (maximum 40 cm H2O).

Primary outcome: Leak pressure Secondary outcome: SGAD insertion time Fiberoptic view Maneuvers Complications. Statistical Analysis the primary outcome is the leak pressure. Previous pilot conducted in 15 children, the average standard deviation leak pressure found to be 31 cm H20. In order to obtain a statistically representative sample for a 95% CI with a margin error of 2% and a standard deviation of 2 cm H20, the sample sizes of 50 cases are needed for each device.

Continuous data presented as mean±SD. For the categorical variables frequencies and percentages will be calculated. SPSS version 20 for statistical analysis. P-values smaller than 0.05 considered statistically significant.

Categorical data will be analyzed with Pearson chi-square test Mann-Whitney U test will be performed to analyze non-normally distributed interval scale data and ordinal categorical data. Normally distributed data will be analyzed by t-tests.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of LTS-D and i-gel in non-paralyzed pediatric patients under general anesthesia: a randomized trial.
   Somri M, Somri F, Gaitini L, Safadi A, et al · · 2025 · PMID 41039946 · DOI 10.5114/ait/208942