Supraglottic Airway DeviceNCT02260427
A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients
A study testing Insertion of the i-gel and Insertion of the air-Q sp in people with Supraglottic Airway Device, run by Yonsei University at 1 site in South Korea.
Trial summary
Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Supraglottic Airway Device
- What is being tested?
- Insertion of the i-gel and Insertion of the air-Q sp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Aug 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. elderly adult patients (65-90 of age) scheduled for elective surgery undergoing general anesthesia using supraglottic airway
Who cannot join
- 1. Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu
Seoul, Seoul, 135-720
About this study
Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q sp is similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients
- Conditions
- Supraglottic Airway Device
- Being tested
- Insertion of the i-gel, Insertion of the air-Q sp
- Keywords
- elective surgery, undergoing general anesthesia, elderly adult patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of the i-gelDevice
After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.
Insertion of the air-Q spDevice
| Study group | Role | What they receive |
|---|---|---|
| the i-gel group | Experimental | After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group. Receives: Device: Insertion of the i-gel |
| the Air-Q sp group | Active comparator | After induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group. Receives: Device: Insertion of the air-Q sp |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway leak pressure measured after device insertion
Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
Measured: within 5min after insertion of each device
Secondary outcomes (1)
insertion parameters (insertion time and ease of insertion)
Insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography. Ease of insertion was graded from 1 to 4.
Measured: During and 1 min after insertion of each device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraglottic Airway DeviceStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min-Soo Kim, MD, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260427
- Sponsor's protocol ID
- 3-2014-0157
- Status last verified
- Sep 2016
- First submitted
- 5 Oct 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.
PubMed 30320644
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients
- ClinicalTrials.gov ID
- NCT02260427
- Acronym / sponsor ID
- 3-2014-0157
- Conditions
- Supraglottic Airway Device
- Keywords
- elective surgery, undergoing general anesthesia, elderly adult patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Oct 2014 (estimated)
- 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.
Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new single-use device that may optimise the airway sealing while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q sp is similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the i-gel group | Experimental | Device: Insertion of the i-gelAfter induction of general anesthesia, the i-gel will be inserted according to randomly allocated group. |
| the Air-Q sp group | Active comparator | Device: Insertion of the air-Q spAfter induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 1. elderly adult patients (65-90 of age) scheduled for elective surgery undergoing general anesthesia using supraglottic airway
Key exclusion criteria (1 listed)
- 1. Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
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 |
|---|---|---|
| Insertion of the i-gelAfter induction of general anesthesia, the i-gel will be inserted according to randomly allocated group. | Device | the i-gel group |
| Insertion of the air-Q sp | Device | the Air-Q sp group |
Primary outcome
airway leak pressure measured after device insertion
Time frame: within 5min after insertion of each device
Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
1 secondary outcome
insertion parameters (insertion time and ease of insertion)
Time frame: During and 1 min after insertion of each device
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 7 Sep 2016.
- Derived from this study: PubMed 30320644Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.
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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.
Min-Soo Kim, MD principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of the i-gel and Insertion of the air-Q sp in people with Supraglottic Airway Device, run by Yonsei University 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 1 inclusion and 1 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 7 Sep 2016. 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 leak pressure measured after device insertion (time frame: within 5min after insertion of each device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02260427, which also lists 1 linked publication.
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 7 Sep 2016.