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

NCT05901753 | Completed

• 1 other identifier: MS-631-2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The time of insertion of supra glottic device

  time interval between picking the device up till appearance of the first wave on the capnogram

  time interval between picking the device up till appearance of the first wave on the capnogram. (seconds)

Secondary Outcomes (1)

• complications

  it will be measured postoperatively at 0, 3, 6 hours

Study Arms (2)

Laryseal pro supra glottic device (SGD)

EXPERIMENTAL

Laryseal pro SGD, the jaw will be lifted during insertion and the head will be extended, proper lubrication of both the front and back of the laryseal pro as if the patient's mouth is dry the laryseal pro ridges can get hung up on the back of the tongue during placement.

Device: Laryseal pro supra glottic device

Laryngeal Mask Airway- Proseal™

EXPERIMENTAL

The LMA-Proseal™ will be inserted using the digit method. The size will be determined according to the patient's weight and inserted according to the manufacture's recommendation with the use of an introducer.

Device: Laryngeal Mask Airway- Proseal™

Interventions

Laryseal pro supra glottic device 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

Also known as: supra glottic device

Laryseal pro supra glottic device (SGD)

Laryngeal Mask Airway- Proseal™ DEVICE

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.

Also known as: supra glottic device

Laryngeal Mask Airway- Proseal™

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both males and females
• Age 18-60 years
• GANZOURI airway scores less than 4
• Patients undergoing ophthalmic surgeries not exceeding two hours under general anesthesia (cataract surgery,glaucoma surgery, corneal transplant, strabismus surgery

You may not qualify if:

• Patients have risks of gastric aspiration (patients known to have gastro esophageal reflux disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery)
• patients have respiratory or pharyngeal pathology
• morbidly obese patients with body mass index \>40 kg/m3

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy, Cairo University

Cairo, 202, Egypt

Location

Study Officials

• Maha Ismael, professor

  Anesthesia department , Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. This study will be performed by 2 investigators; the first one (implementing doctor) who will insert supra glottic airway device based on patients' weight as per the manufacturers' size recommendations and according to a computer-generated sequence of random numbers and sealed envelope. The second anesthetists (planning doctor) will be blinded to the technique performed, and will monitor the patients intra and postoperatively.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: June 13, 2023
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)