Comparison of Gastric Insufflation With the Classic Igel Laryngeal Mask and the New Igelplus Laryngeal Mask Using Gastric Ultrasound

Comparison of Gastric Air Insufflation and Ventilation Between Two Laryngeals Masks (LMA): Igel and Igelplus

This study aims to compare the effectiveness and safety of two types of laryngeal masks- iGel and iGel Plus, used during elective surgeries. The focus is on evaluating differences in gastric insufflation and ventilation parameters between these two devices. Participants will be patients classified as ASA 1-2 with a BMI of less than 35, undergoing elective procedures.

The study is designed as a prospective, randomized, controlled trial with 200 subjects divided evenly between the two laryngeal mask groups. Key outcomes include gastric cross-sectional area (CSA) measurements before and after surgery, ventilation metrics such as leakage pressure and PEEP, and the incidence of postoperative complications like nausea and respiratory issues.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Anesthesia
• Intervention / Treatment: Device: Igelplus

Detailed Description

A Comparative Study of Gastric Insufflation and Ventilation Parameters Between iGel and iGel Plus Laryngeal Masks in Elective Outpatient Surgeries

Laryngeal masks (LM) are commonly used in airway management during elective surgeries as they offer a less invasive alternative to endotracheal intubation, providing effective ventilation while reducing the risk of trauma to the airway. Among the available options, the iGel laryngeal mask and its advanced version, the iGel Plus, have gained popularity. The iGel mask is known for its unique, non-inflatable cuff that conforms to the patient's anatomy, providing a secure fit and minimizing the risk of airway complications. The iGel Plus is an enhanced version designed to improve anatomical fit, reduce the incidence of leaks, and potentially decrease the risk of gastric insufflation.

The purpose of this study is to investigate the differences in gastric insufflation and ventilation parameters when using the iGel versus the iGel Plus laryngeal mask during elective surgical procedures. Given the potential benefits of the iGel Plus in optimizing airway management and reducing postoperative complications, this study aims to provide clinical evidence to guide the selection of laryngeal masks in practice.

The primary objective is to compare the incidence and extent of gastric insufflation between the iGel and iGel Plus laryngeal masks. Secondary, we want to assess and compare ventilation parameters, including leakage pressure, inspiratory pressure (Pinsp), positive end-expiratory pressure (PEEP), and the number of insertion attempts required for effective mask placement. Additionally, the study will evaluate the incidence of postoperative complications such as nausea, sore throat, and respiratory complications (SpO2 < 92%).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with ASA classification 1-2
• Undergoing elective surgery
• Body Mass Index (BMI) < 35
• No contraindications for the laryngeal mask

Exclusion Criteria:

• Presence of contraindications for the laryngeal mask
• Urgent or non-elective surgeries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Igel; Control device	Device: Igelplus; Intubation with Igelplus laryngeal mask
Active Comparator: Igelplus; Study device	Device: Igelplus; Intubation with Igelplus laryngeal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crosssectional are of stomach	Sonographic Measurement of gastric CSA	5 minutes before anesthesia induction, during the surgery and 5 minutes after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator Parameters	Ventilator parameters like Inspiratory pressure (Pinsp), positive end expiratory pressure (PEEP) and leakage pressure in mmH2O	during the surgery
Insertions of laryngeal mask	How many atempts were needed to insert the laryngeal mask	during the induction of anesthesia (at the initiation of anesthesia)
postoperative complications	Nausea and vomiting, respiratory complications	after the surgery in recovery room

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Igelplus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No