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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06578598
Enrollment
200
Registered
2024-08-29
Start date
2024-10-01
Completion date
2025-12-01
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Surgery

Brief summary

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.

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%).

Interventions

DEVICEIgelplus

Intubation with Igelplus laryngeal mask

Sponsors

Luzerner Kantonsspital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Crosssectional are of stomach5 minutes before anesthesia induction, during the surgery and 5 minutes after the surgerySonographic Measurement of gastric CSA

Secondary

MeasureTime frameDescription
Ventilator Parametersduring the surgeryVentilator parameters like Inspiratory pressure (Pinsp), positive end expiratory pressure (PEEP) and leakage pressure in mmH2O
Insertions of laryngeal maskduring the induction of anesthesia (at the initiation of anesthesia)How many atempts were needed to insert the laryngeal mask
postoperative complicationsafter the surgery in recovery roomNausea and vomiting, respiratory complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026