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

NCT05503277 | Unknown DMC

• 1 other identifier: 0117-22-BNZ
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Supraglottic devices; ltsd; i-gel; pediatric; seal pressure

Outcome Measures

Primary Outcomes (1)

• Seal pressure

  Measuring seal pressure

  60 seconds

Secondary Outcomes (1)

• Device Insertion

  30 seconds

Study Arms (2)

Superglottic airway device LTSD

ACTIVE COMPARATOR

measuring seal pressure

Device: LTSD

Superglottic airway device i-gel

ACTIVE COMPARATOR

measuring seal pressure

Device: i-gel

Interventions

LTSD DEVICE

measuring seal pressure

Superglottic airway device LTSD

i-gel DEVICE

measuring seal pressure

Superglottic airway device i-gel

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA I
• ELECTIVE SURGRY

You may not qualify if:

• ASA II OR MORE
• At risk for aspiration
• Upper respiratory tract symptoms within former 10 days
• Congenital anatomical malformation
• A possible difficult airway by history or physical examination.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Officials

• Mostafa Somri, DR MD

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Somri, Dr MD

CONTACT

972-50-6267289; mostafa.somri@b-zion.org.il

Luis Gaitini, Dr MD

CONTACT

972-50-6223999; luis.gaitini@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Anesthesiology

Model Details: observational

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 16, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 31, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share