I-gel vs. Endotracheal Intubation for Laparoscopic Gynaecological Procedures

NCT ID: NCT05782517

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-11
• Study Completion Date: 2024-10-21

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.

Detailed Description

The NoTube study aims to compare an I-gel laryngeal mask with an endotracheal tube (ETT) during gynaecological keyhole surgery (laparoscopy) as part of a fertility trajectory.

Laparoscopy requires general anaesthesia. During this general anaesthesia, the airway is secured. Classically, this is done with an endotracheal tube. This is a hollow tube between the vocal cords (in the trachea) through which the anaesthetist can support the patient's breathing during the procedure. This procedure is also called intubation. A muscle relaxant is given to make the placement of an endotracheal tube easier. Placing an endotracheal tube during laparoscopic procedures is still considered the 'gold standard'. The lungs are protected from the aspiration of stomach contents. The principal risks of intubation are tissue damage (e.g., to the lips and trachea), sore throat and damage to tooth elements.

An alternative to an endotracheal tube is a laryngeal mask. A laryngeal mask is sometimes called a 'supraglottis device' because it is inserted above the vocal cords (glottis). A laryngeal mask is generally easier to insert, no muscle relaxation is required, and there is also less risk of sore throat and less chance of tooth damage. Since the laryngeal mask does not pass through the vocal cords, there is less protection against aspiration of stomach contents.

With the arrival of newer laryngeal masks (e.g. the I-gel laryngeal mask), they are increasingly used as an alternative to an endotracheal tube during short, laparoscopic procedures. From initial studies, a laryngeal mask appears to be as effective as an endotracheal tube, with fewer side effects, such as a sore throat. Initial investigations suggest no higher risk of aspiration of gastric contents. However, there are no studies yet comparing the use of an I-gel with an endotracheal tube during short laparoscopic procedures in the context of a fertility trajectory where the whole population (i.e., patients with a BMI higher than 35kg/m²) can participate in the study.

This study will assign patients to either the endotracheal or the I-gel group. The anaesthetic during the procedure is the same in the two groups. In the endotracheal group, an additional muscle relaxant will be given. After the procedure, the patient answers some questions about possible discomforts (e.g. sore throat, hoarseness...). The patient also completes a similar questionnaire on the first day after surgery. On day three after surgery, a study officer calls the patient to review some questions again. Finally, the patient receives a final questionnaire at the end of sick leave.

Conditions

Intubation Complication; Laryngeal Mask Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

I-gel

Group Type: EXPERIMENTAL

Supraglottic Airway Device

Intervention Type: DEVICE

Placement of an I-gel Supraglottic Airway Device.

Endotracheal Tube

Group Type: ACTIVE_COMPARATOR

Endotracheal Tube

Intervention Type: DEVICE

Placement of an Endotracheal Tube.

Interventions

Supraglottic Airway Device

Placement of an I-gel Supraglottic Airway Device.

Intervention Type: DEVICE

Endotracheal Tube

Placement of an Endotracheal Tube.

Intervention Type: DEVICE

Other Intervention Names

I-gel; Laryngeal Mask; Portex Tracheal Tube; ETT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Brussel

Jette, Brussels Capital, Belgium

Countries

Belgium

Other Identifiers

22228NoTube

Identifier Type: -

Identifier Source: org_study_id