Airway Management in Elderly Patients Using Supra Glottic Airway Under General AnesthesiaNCT07125677
Comparison of I-gel and I-gel Plus in Elderly Patients
A study testing I-gel first, I-gel plus first and common in people with Airway Management in Elderly Patients Using Supra Glottic Airway Under General Anesthesia, run by Dongguk University International Hospital at 1 site in South Korea.
Trial summary
This study compares the airway sealing pressure between I-gel® and I-gel plus® in elderly patients (aged 65-85) undergoing general anesthesia. I-gel® is a supraglottic airway device with a non-inflatable cuff, and I-gel plus® is an improved version with a larger gastric drainage channel, enhanced airway tube, and… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Airway Management in Elderly Patients Using Supra Glottic Airway Under General Anesthesia
- What is being tested?
- I-gel first, I-gel plus first and common
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2025to 23 Jun 2026
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65-85 years with ASA physical status I-III.
- Scheduled for elective surgery under general anesthesia lasting less than 3 hours.
Who cannot join
- High risk of aspiration (history of gastrectomy, BMI >35 kg/m², gastroesophageal reflux disease, hiatal hernia).
- Poor dental status preventing I-gel fixation.
- Cervical spine instability.
- Anatomical abnormalities in mouth or larynx, or high risk of respiratory complications (asthma, COPD, recent pneumonia).
- Pregnancy.
- Other cases deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10323
About this study
Official title: Comparison of Airway Sealing Pressure Between I-gel® and I-gel Plus® in Elderly Patients Under General Anesthesia
This study compares the airway sealing pressure between I-gel® and I-gel plus® in elderly patients (aged 65-85) undergoing general anesthesia. I-gel® is a supraglottic airway device with a non-inflatable cuff, and I-gel plus® is an improved version with a larger gastric drainage channel, enhanced airway tube, and longer cuff tip for better sealing. The study aims to evaluate differences in sealing pressure and other performance metrics in this population, where anatomical changes may affect device efficacy.
Read the detailed description
Supraglottic airway devices (SGAs) are widely used as alternatives to endotracheal intubation in anesthesiology and emergency medicine. The I-gel® (Intersurgical Ltd., UK) features a non-inflatable cuff for ease of insertion and excellent sealing. The I-gel plus® improves on this with a larger gastric channel, better airway tube, and extended cuff tip to enhance sealing pressure.
Prior studies compared I-gel® to other SGAs like ProSeal or Supreme, showing variable sealing pressures, but direct comparisons between I-gel® and I-gel plus®, especially in elderly patients, are lacking. Elderly patients may experience upper airway anatomical changes affecting SGA performance. Higher sealing pressure is crucial for surgeries with increased intra-abdominal pressure (e.g., laparoscopic or robotic surgery) and can reduce respiratory complications in patients with airway hypersensitivity.
This prospective crossover study will quantitatively assess differences in sealing pressure, fixation stability, and other outcomes. Both devices are approved by the Korean MFDS and will be used within approved indications for academic evaluation of efficacy in elderly patients.
- Being tested
- I-gel first, I-gel plus first, common
- Keywords
- I-gel study, SGA study, Elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gel firstDevice
After general anesthesia, I-gel is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel plus is inserted, and the same procedure is repeated.
I-gel plus firstDevice
After general anesthesia, I-gel plus is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel is inserted, and the same procedure is repeated.
commonBehavioural
Prior to general anesthesia, as a common baseline procedure for all study arms, the patient's Charlson Comorbidity Index and frailty score are assessed and recorded through patient evaluation (using the Clinical Frailty Scale for the frailty score). Immediately before induction of anesthesia, progressive pressures (100 g, 200 g, 300 g, 400 g, and 500 g) are applied to the patient's thyroid cartilage, and the degree of deviation is measured and documented.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients receive I-gel® first, followed by removal and insertion of I-gel plus®. Receives: Device: I-gel first; Behavioral: common |
| Group P | Active comparator | Patients receive I-gel plus® first, followed by removal and insertion of I-gel®. Receives: Device: I-gel plus first; Behavioral: common |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Sealing Pressure
Comparison of sealing pressure (cm H2O) between I-gel® and I-gel plus®, measured after insertion with fresh gas flow at 3 L/min and valve closed.
Measured: During surgery, immediately after each device insertion
Secondary outcomes (4)
Fixation Stability
Assessment of device position maintenance after insertion (device movement yes/no).
Measured: During surgery
Time to Successful Insertion
Time from start of insertion to complete EtCO2 curve appearance (twice).
Measured: During surgery
Ease of Insertion
Graded as 1 (success on first attempt, no resistance), 2 (success on first, with resistance), 3 (success after >1 attempt).
Measured: During surgery
Operator Complications
Incidence of sore throat, laryngospasm, voice hoarseness, dysphagia.
Measured: Post-surgery up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start17 Nov 2025
- Primary completion23 Jun 2026
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Management in Elderly Patients Using Supra Glottic Airway Under General AnesthesiaStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Prospective crossover design where patients are randomized to receive either I-gel first followed by I-gel plus (Group I) or vice versa (Group P)
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongguk University International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hansu Bae, Dongguk University International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125677
- Sponsor's protocol ID
- DUIH 2025-04-012-003
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be managed confidentially and stored for 3 years post-study, then destroyed per privacy laws. No sharing planned.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Airway Sealing Pressure Between I-gel® and I-gel Plus® in Elderly Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07125677
- Acronym / sponsor ID
- DUIH 2025-04-012-003
- Keywords
- I-gel study, SGA study, Elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dongguk University International HospitalUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 15 Aug 2025 (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.
This study compares the airway sealing pressure between I-gel® and I-gel plus® in elderly patients (aged 65-85) undergoing general anesthesia. I-gel® is a supraglottic airway device with a non-inflatable cuff, and I-gel plus® is an improved version with a larger gastric drainage channel, enhanced airway tube, and longer cuff tip for better sealing. The study aims to evaluate differences in sealing pressure and other performance metrics in this population, where anatomical changes may affect device efficacy.
Detailed description
Supraglottic airway devices (SGAs) are widely used as alternatives to endotracheal intubation in anesthesiology and emergency medicine. The I-gel® (Intersurgical Ltd., UK) features a non-inflatable cuff for ease of insertion and excellent sealing. The I-gel plus® improves on this with a larger gastric channel, better airway tube, and extended cuff tip to enhance sealing pressure.
Prior studies compared I-gel® to other SGAs like ProSeal or Supreme, showing variable sealing pressures, but direct comparisons between I-gel® and I-gel plus®, especially in elderly patients, are lacking. Elderly patients may experience upper airway anatomical changes affecting SGA performance. Higher sealing pressure is crucial for surgeries with increased intra-abdominal pressure (e.g., laparoscopic or robotic surgery) and can reduce respiratory complications in patients with airway hypersensitivity.
This prospective crossover study will quantitatively assess differences in sealing pressure, fixation stability, and other outcomes. Both devices are approved by the Korean MFDS and will be used within approved indications for academic evaluation of efficacy in elderly patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective crossover design where patients are randomized to receive either I-gel first followed by I-gel plus (Group I) or vice versa (Group P)
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: I-gel first, Behavioral: commonPatients receive I-gel® first, followed by removal and insertion of I-gel plus®. |
| Group P | Active comparator | Device: I-gel plus first, Behavioral: commonPatients receive I-gel plus® first, followed by removal and insertion of I-gel®. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients aged 65-85 years with ASA physical status I-III.
- Scheduled for elective surgery under general anesthesia lasting less than 3 hours.
Key exclusion criteria (6 listed)
- High risk of aspiration (history of gastrectomy, BMI >35 kg/m², gastroesophageal reflux disease, hiatal hernia).
- Poor dental status preventing I-gel fixation.
- Cervical spine instability.
- Anatomical abnormalities in mouth or larynx, or high risk of respiratory complications (asthma, COPD, recent pneumonia).
- Pregnancy.
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 |
|---|---|---|
| I-gel firstAfter general anesthesia, I-gel is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel plus is inserted, and the same procedure is repeated. | Device | Group I |
| I-gel plus firstAfter general anesthesia, I-gel plus is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel is inserted, and the same procedure is repeated. | Device | Group P |
| commonPrior to general anesthesia, as a common baseline procedure for all study arms, the patient's Charlson Comorbidity Index and frailty score are assessed and recorded through patient evaluation (using the Clinical Frailty Scale for the frailty score). Immediately before induction of anesthesia, progressive pressures (100 g, 200 g, 300 g, 400 g, and 500 g) are applied to the patient's thyroid cartilage, and the degree of deviation is measured and documented. | Behavioural | Group I, Group P |
Primary outcome
Airway Sealing Pressure
Time frame: During surgery, immediately after each device insertion
Comparison of sealing pressure (cm H2O) between I-gel® and I-gel plus®, measured after insertion with fresh gas flow at 3 L/min and valve closed.
4 secondary outcomes
Fixation Stability
Time frame: During surgery
Time to Successful Insertion
Time frame: During surgery
Ease of Insertion
Time frame: During surgery
Operator Complications
Time frame: Post-surgery up to 24 hours
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 10 Jul 2026.
- Individual participant dataSharing planned: No. Data will be managed confidentially and stored for 3 years post-study, then destroyed per privacy laws. No sharing planned.
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 I-gel first, I-gel plus first and common in people with Airway Management in Elderly Patients Using Supra Glottic Airway Under General Anesthesia, run by Dongguk University International Hospital at 1 site in South Korea.
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 6 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 10 Jul 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 South Korea. 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?
Airway Sealing Pressure (time frame: During surgery, immediately after each device insertion). 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 10 Jul 2026.