SurgeryNCT02206438
The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)
A study testing Insertion of C-LMA and Insertion of air-Q according in people with Surgery, 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 ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q (air-Q) is newly developed supraglottic airway devices. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Surgery
- What is being tested?
- Insertion of C-LMA and Insertion of air-Q according
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Mar 2015
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (20-75 of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Who cannot join
- 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
Human research Protection Center, Gangnam Severance Hospital,
Seoul, 120-752
About this study
Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q (air-Q) 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 identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the classic LMA and the air-Q SP.
- Conditions
- Surgery
- Being tested
- Insertion of C-LMA, Insertion of air-Q according
- Keywords
- supraglottic airway devices, the classic laryngeal mask airway, the self-pressurised air-Q intubating laryngeal airway in adult patients, elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway in adult patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of C-LMADevice
After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
Insertion of air-Q accordingDevice
After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
| Study group | Role | What they receive |
|---|---|---|
| 1)C-LMA group | Experimental | Not described Receives: Device: Insertion of C-LMA |
| 2)Air-Q group | Active comparator | Not described Receives: Device: Insertion of air-Q according |
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 to 10 min insertion of each device
Secondary outcomes (1)
Insertion time
Insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography.
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 posted1 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
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 SurgeryStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206438
- Sponsor's protocol ID
- 3-2014-0081
- Status last verified
- Oct 2016
- First submitted
- 28 Jul 2014
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ha SH, Kim MS, Suh J, Lee JS. Self-pressurized air-Q(R) intubating laryngeal airway versus the LMA(R) Classic: a randomized clinical trial. Can J Anaesth. 2018 May;65(5):543-550. doi: 10.1007/s12630-018-1082-6. Epub 2018 Feb 6.
PubMed 29524199
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)
- ClinicalTrials.gov ID
- NCT02206438
- Acronym / sponsor ID
- 3-2014-0081
- Conditions
- Surgery
- Keywords
- supraglottic airway devices, the classic laryngeal mask airway, the self-pressurised air-Q intubating laryngeal airway in adult patients, elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway in adult patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Aug 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 ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q (air-Q) 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 identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the classic LMA and the air-Q SP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1)C-LMA group | Experimental | Device: Insertion of C-LMA |
| 2)Air-Q group | Active comparator | Device: Insertion of air-Q according |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (20-75 of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Key exclusion criteria (1 listed)
- 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 C-LMAAfter induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group. | Device | 1)C-LMA group |
| Insertion of air-Q accordingAfter induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group. | Device | 2)Air-Q group |
Primary outcome
airway leak pressure measured after device insertion
Time frame: within 5min to 10 min 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 time
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 11 Jan 2019.
- Derived from this study: PubMed 29524199Ha SH, Kim MS, Suh J, Lee JS. Self-pressurized air-Q(R) intubating laryngeal airway versus the LMA(R) Classic: a randomized clinical trial. Can J Anaesth. 2018 May;65(5):543-550. doi: 10.1007/s12630-018-1082-6. Epub 2018 Feb 6.
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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 Insertion of C-LMA and Insertion of air-Q according in people with Surgery, 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 11 Jan 2019. 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 to 10 min 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 NCT02206438, 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 11 Jan 2019.