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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuzerner Kantonsspital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with ASA classification 1-2

Undergoing elective surgery

Body Mass Index (BMI) < 35

No contraindications for the laryngeal mask

Disqualifiers

Presence of contraindications for the laryngeal mask

Urgent or non-elective surgeries

Trial design

Design model

Crossover

Treatments tested in this trial

  • Igelplus

    Device

    Intubation with Igelplus laryngeal mask

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: IgelSham comparator 1 intervention
Group B: IgelplusActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Crosssectional are of stomach

Sonographic Measurement of gastric CSA

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

Secondary outcomes

1

Ventilator Parameters

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

Time frame
during the surgery
2

Insertions of laryngeal mask

How many atempts were needed to insert the laryngeal mask

Time frame
during the induction of anesthesia (at the initiation of anesthesia)
3

postoperative complications

Nausea and vomiting, respiratory complications

Time frame
after the surgery in recovery room

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: