Intubation ComplicationNoTubeNCT05782517
I-gel vs. Endotracheal Intubation for Laparoscopic Gynaecological Procedures
A study testing Supraglottic Airway Device and Endotracheal Tube in people with Intubation Complication and Laryngeal Mask Complication, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intubation Complication, Laryngeal Mask Complication
- What is being tested?
- Supraglottic Airway Device and Endotracheal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Oct 2023to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The expected duration of the procedure does not exceed 2 hours
- Agreeing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I-gel Laryngeal Mask Versus Endotracheal Intubation for Laparoscopic Gynaecological Procedures (NoTube Study)
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.
Read the 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.
- Being tested
- Supraglottic Airway Device, Endotracheal Tube
- Keywords
- I-gel, Endotracheal Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraglottic Airway DeviceDevice
Also called I-gel, Laryngeal Mask
Placement of an I-gel Supraglottic Airway Device.
Endotracheal TubeDevice
Also called Portex Tracheal Tube, ETT
Placement of an Endotracheal Tube.
| Study group | Role | What they receive |
|---|---|---|
| I-gel | Experimental | Not described Receives: Device: Supraglottic Airway Device |
| Endotracheal Tube | Active comparator | Not described Receives: Device: Endotracheal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A maximum of three tries is attempted before converting to a different technique.
Measured: Immediately after placement of the airway device.
Total induction time
Time from when the palpebral reflex of the patient is abolished until the appearance of the first capnography square waveform.
Measured: Immediately after completion of the first capnography square waveform.
Number of manipulations of the airway device
The number of times the anaesthesiologist manipulates the airway device to ensure adequate ventilation.
Measured: During surgery
Blood staining on the airway device
It is noted whether there is blood staining of the airway device.
Measured: Immediately after removing the airway device
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
Measured: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal.
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
Measured: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
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
Measured: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
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
Measured: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
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.
Measured: Postoperative day one, day three and either day seven (for diagnostic laparoscopies) or day 14 (for all other surgeries).
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
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start11 Oct 2023
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782517
- Sponsor's protocol ID
- 22228NoTube
- Acronym
- NoTube
- Status last verified
- Sep 2024
- First submitted
- 21 Dec 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-gel Laryngeal Mask Versus Endotracheal Intubation for Laparoscopic Gynaecological Procedures (NoTube Study)
- ClinicalTrials.gov ID
- NCT05782517
- Acronym / sponsor ID
- NoTube / 22228NoTube
- Keywords
- I-gel, Endotracheal Tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-gel | Experimental | Device: Supraglottic Airway Device |
| Endotracheal Tube | Active comparator | Device: Endotracheal Tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The expected duration of the procedure does not exceed 2 hours
- Agreeing to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraglottic Airway DeviceAlso: I-gel, Laryngeal MaskPlacement of an I-gel Supraglottic Airway Device. | Device | I-gel |
| Endotracheal TubeAlso: Portex Tracheal Tube, ETTPlacement of an Endotracheal Tube. | Device | Endotracheal Tube |
Primary outcome
Leak fraction
Time frame: 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.
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.
10 secondary outcomes
Number of attempts for placement of the airway device
Time frame: Immediately after placement of the airway device.
Total induction time
Time frame: Immediately after completion of the first capnography square waveform.
Number of manipulations of the airway device
Time frame: During surgery
Blood staining on the airway device
Time frame: Immediately after removing the airway device
The presence of nausea and vomiting
Time frame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal.
The presence of dysphagia
Time frame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
The presence of hoarseness
Time frame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
The presence of respiratory complications
Time frame: 30 minutes after removal of the airway device, 1 hour after removal and 2 hours after removal
Overall satisfaction
Time frame: Postoperative day one, day three and either day seven (for diagnostic laparoscopies) or day 14 (for all other surgeries).
Quality of the surgical working conditions
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraglottic Airway Device and Endotracheal Tube in people with Intubation Complication and Laryngeal Mask Complication, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leak fraction (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.