Clinical trial NCT05782517: I-gel vs. Endotracheal Intubation for Laparoscopic Gynaecological Procedures
Official title: I-gel Laryngeal Mask Versus Endotracheal Intubation for Laparoscopic Gynaecological Procedures (NoTube Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation Complication
Laryngeal Mask Complication
Keywords: I-gel
Endotracheal Tube
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Leak fraction
timeFrame: 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:
measure: Number of attempts for placement of the airway device
timeFrame: Immediately after placement of the airway device.
measure: Total induction time
timeFrame: Immediately after completion of the first capnography square waveform.
measure: Number of manipulations of the airway device
timeFrame: During surgery
measure: Blood staining on the airway device
timeFrame: Immediately after removing the airway device
measure: The presence of nausea and vomiting
timeFrame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal.
measure: The presence of dysphagia
timeFrame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
measure: The presence of hoarseness
timeFrame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
measure: The presence of respiratory complications
timeFrame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
measure: Overall satisfaction
timeFrame: Postoperative day one, day three and either day seven (for diagnostic laparoscopies) or day 14 (for all other surgeries).
measure: Quality of the surgical working conditions
timeFrame: During surgery
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References: