I-gel vs. Endotracheal Intubation for Laparoscopic Gynaecological Procedures

NCT05782517 | Completed

• 1 other identifier: 22228NoTube
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to compare the I-gel laryngeal mask, a type of supraglottic airway device (SGA), with endotracheal intubation in terms of safety, ease of use and adverse side effects for patients during gynecologic laparoscopic procedures at the Brussels Fertility Center in Brussels, Belgium.

Conditions

Intubation Complication; Laryngeal Mask Complication

Keywords

I-gel; Endotracheal Tube

Outcome Measures

Primary Outcomes (1)

• Leak fraction

  The leak fraction is defined as the leak volume divided by the inspired tidal volume. The leak volume is the difference between the inspired and expired tidal volumes.

  Thirty seconds after placement of the airway device, 30 seconds after completing insufflation of the abdomen, 30 seconds after positioning the patient in 30° Trendelenburg, every 10 minutes Trendelenburg, and 30 seconds after closing the fascia.

Secondary Outcomes (10)

• Number of attempts for placement of the airway device

  Immediately after placement of the airway device.

• Total induction time

  Immediately after completion of the first capnography square waveform.

• Number of manipulations of the airway device

  During surgery

• Blood staining on the airway device

  Immediately after removing the airway device

• The presence of nausea and vomiting

  30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal.

Study Arms (2)

I-gel

EXPERIMENTAL

Device: Supraglottic Airway Device

Endotracheal Tube

ACTIVE COMPARATOR

Device: Endotracheal Tube

Interventions

Endotracheal Tube DEVICE

Placement of an Endotracheal Tube.

Also known as: Portex Tracheal Tube, ETT

Endotracheal Tube

Supraglottic Airway Device DEVICE

Placement of an I-gel Supraglottic Airway Device.

Also known as: I-gel, Laryngeal Mask

I-gel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only patients of female biological sex are eligible for inclusion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The expected duration of the procedure does not exceed 2 hours
• Agreeing to participate in the study

You may not qualify if:

• The expected duration of the procedure is longer than 2 hours
• The patient suffers from restricted mouth opening, trismus, recent oral trauma or oral abscesses
• The patient has a BMI of more than 40 kg/m²
• The patient is known to have gastroparesis or another risk factor that would prevent you from being sober during the procedure

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: March 23, 2023
• Study Start: October 11, 2023
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: January 15, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)