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

NCT06578598 | Not Yet Recruiting DMC

• 1 other identifier: Igelplus
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Crosssectional are of stomach

  Sonographic Measurement of gastric CSA

  5 minutes before anesthesia induction, during the surgery and 5 minutes after the surgery

Secondary Outcomes (3)

• Ventilator Parameters

  during the surgery

• Insertions of laryngeal mask

  during the induction of anesthesia (at the initiation of anesthesia)

• postoperative complications

  after the surgery in recovery room

Study Arms (2)

Igel

SHAM COMPARATOR

Control device

Device: Igelplus

Igelplus

ACTIVE COMPARATOR

Study device

Device: Igelplus

Interventions

Igelplus DEVICE

Intubation with Igelplus laryngeal mask

Igel; Igelplus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 29, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08