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A Comparative Study Between Laryseal Pro Supra Glottic Device (SGD) With Proseal Laryngeal Mask Airway

NCT05901753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-07

No results posted yet for this study

Summary

Difficult airway is a nightmare to every anesthetist. Over the last decade, several supraglottic airway devices appeared in the clinical field as an alternative to the more invasive endotracheal intubation(1). However, many anesthetists found themselves unaccustomed with the newly invented devices .Supraglottic airway devices (SAD) have become valuable for both routine and difficult airway management. After the creation of the laryngeal mask airway (LMA) classic in the 1980s, there has been a steady increase in the applications for use of supraglottic airways. Developed by Dr. Archie Brain in 2000, the ProSeal laryngeal mask airway (P-LMA) is a second-generation supraglottic airway device (SAD) with two lumens separating the alimentary and respiratory channels from each other This study aim to compare the use of the Laryseal Pro and the Proseal LMA as a supraglottic devices by measuring the time of insertion (which is defined as time interval in seconds between removing the ventilation mask and picking the device up till connecting to the ventilator and appearance of the first wave on the capnogram)

Objectives:

To determine ease of insertion for each supra glotic device. To Estimate the time needed for insertion for each supra glotic device. To identify airway pressure leakage, gastric tube insertion success and complication for each device.

It is hypothesized that the Laryseal pro is a safe superior supraglottic airway device and its insertion is easier than the LMA-Proseal .

Conditions

  • Ophthalmic Surgery

Interventions

DEVICE

Laryseal pro supra glottic device

The laryseal pro SP will be advanced at a forward angle aiming for the back of the tongue and soft palate. Then the colored connector will be pushed by index finger till feeling resistance . Device insertion will be considered successful by observing bilateral chest wall movement as well as a stable square-wave capnogram trace

DEVICE

Laryngeal Mask Airway- Proseal™

The cuff will be inflated with air and the cuff's pressure will be adjusted to 70 mmHg using a cuff pressure manometer. the device will be lubricated well on both sides, head and neck were placed in neutral position, the proximal firmer part of the device will be compressed between the thumb and two fingers and advanced toward hard and soft palate, the tab will be pulled slightly if needed to increase curvature of the device for better fitting, the device will be advanced till resistance felt.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Maha Ismael, professor · Anesthesia department , Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2023-11-06
Completion
2023-11-06

Countries

  • Egypt

Study Locations

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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 NCT05901753 on ClinicalTrials.gov