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

NCT05503277 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-16

No results posted yet for this study

Summary

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.

Conditions

  • Seal Pressure

Interventions

DEVICE

LTSD

measuring seal pressure

DEVICE

i-gel

measuring seal pressure

Sponsors & Collaborators

  • Bnai Zion Medical Center

    lead OTHER_GOV

Principal Investigators

  • Mostafa Somri, DR MD · Bnai Zion Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-11-01
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05503277 on ClinicalTrials.gov