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NCT Number: NCT06578598

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

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.

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Key information

Conditions

Surgery Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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%).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Igelplus

Device

Intubation with Igelplus laryngeal mask

Primary outcomes

  1. Crosssectional are of stomach

    Time frame: 5 minutes before anesthesia induction, during the surgery and 5 minutes after the surgery

    Sonographic Measurement of gastric CSA

Secondary outcomes

  1. Ventilator Parameters

    Time frame: during the surgery

    Ventilator parameters like Inspiratory pressure (Pinsp), positive end expiratory pressure (PEEP) and leakage pressure in mmH2O

  2. Insertions of laryngeal mask

    Time frame: during the induction of anesthesia (at the initiation of anesthesia)

    How many atempts were needed to insert the laryngeal mask

  3. postoperative complications

    Time frame: after the surgery in recovery room

    Nausea and vomiting, respiratory complications

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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