I-gel vs. Endotracheal Intubation for Laparoscopic Gynaecological Procedures

Intubation Complication Clinical Trial

— NoTube  

Official title:

I-gel Laryngeal Mask Versus Endotracheal Intubation for Laparoscopic Gynaecological Procedures (NoTube Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782517
• Other study ID #: 22228NoTube
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: Annelies Scholliers, MD
• Phone: +32472743784
• Email: annelies.scholliers[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Device:
• Supraglottic Airway Device
Placement of an I-gel Supraglottic Airway Device.
• Endotracheal Tube
Placement of an Endotracheal Tube.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of attempts for placement of the airway device	A maximum of three tries is attempted before converting to a different technique.	Immediately after placement of the airway device.
Secondary	Total induction time	Time from when the palpebral reflex of the patient is abolished until the appearance of the first capnography square waveform.	Immediately after completion of the first capnography square waveform.
Secondary	Number of manipulations of the airway device	The number of times the anaesthesiologist manipulates the airway device to ensure adequate ventilation.	During surgery
Secondary	Blood staining on the airway device	It is noted whether there is blood staining of the airway device.	Immediately after removing the airway device
Secondary	The presence of nausea and vomiting	Grading of nausea severity: 0: No nausea; 1: Mild nausea, not requesting pharmacological rescue; 2: Moderate nausea, requesting pharmacological rescue; 3: Severe nausea resistant to pharmacological treatment; Grading of Vomiting severity: 0: No vomiting; 1: Mild Vomiting, not requesting pharmacological rescue; 2: Moderate vomiting, requesting pharmacological rescue; 3: Severe vomiting, resistant to pharmacological treatment	30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal.
Secondary	The presence of dysphagia	Presence of dysphagia: 0: no dysphagia; 1: Mild, only rare episodes, not considered a significant problem; 2: Moderate, occasional difficulty swallowing specific foods (e.g. steak); 3: Severe, frequent difficulties swallowing the majority of food	30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
Secondary	The presence of hoarseness	Presence of hoarseness: 0: No hoarseness present; 1: Hoarseness noted by the patient; 2: Mild readily apparent hoarseness of voice; 3: Severe readily apparent hoarseness of voice	30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
Secondary	The presence of respiratory complications	Grade 0: no respiratory complications; Grade 1: Any deviation from normal postoperative course without the need of pharmacological treatment or surgical, endoscopic and radiological intervention.; Grade 2: Requiring specific pharmacological treatment. For example, pneumonia requiring antibiotics.; Grade 3: Requiring surgical, endoscopic or radiological intervention.; Grade 4: Life-threatening condition requiring intensive care unit (ICU) admission	30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
Secondary	Overall satisfaction	An online questionnaire completed by the patient. Pain intensity will be recorded using a visual analogue scale and measuring the distance between the 'no pain' point (0 millimeters) and the patient's mark. A longer distance equals more intense pain.	Postoperative day one, day three and either day seven (for diagnostic laparoscopies) or day 14 (for all other surgeries).
Secondary	Quality of the surgical working conditions	The surgeon is asked every 10 minutes to asses the quality of the surgical conditions using the Leiden Surgical Rating Scale (L-SRS). The L-SRS is a Likert scale ranging from 1 to 5 where 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions	During surgery