Mechanical VentilationNCT03078517
Comparison of the LMA Protector and the I-gel
A study testing I-gel and Laryngeal mask airway protector in people with Mechanical Ventilation, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- I-gel and Laryngeal mask airway protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2017to 20 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirement for mechanical ventilation under general anesthesia
Who cannot join
- Surgical position other than supine position
- Tumors or anatomical abnormalities in the upper airway
- Known or predicted difficult airway
- Body mass index > 30 kg/m2
- Required postoperative mechanical ventilation
- Head and neck surgery
- Aspiration tendency
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: Comparison of the LMA Protector and the I-gel in Anesthetized Patients.
Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.
- Conditions
- Mechanical Ventilation
- Being tested
- I-gel, Laryngeal mask airway protector
- Keywords
- I-gel, Laryngeal mask airway protector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gelDevice
After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.
Laryngeal mask airway protectorDevice
After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.
| Study group | Role | What they receive |
|---|---|---|
| I-gel group | Active comparator | After the induction of anesthesia, I-gel is inserted into the oropharyngeal space. Receives: Device: I-gel |
| LMA protector group | Experimental | After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space. Receives: Device: Laryngeal mask airway protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal airway leak pressure
Oropharyngeal airway leak pressure is measured by closing the expiratory valve of the circle system at a fresh gas flow of 3 L/min and observing the airway pressure at equilibrium.
Measured: At 5 min after the insertion of i-gel or LMA protector
Secondary outcomes (7)
Number of insertion attempt for the successful placement
The numbers of insertion attempt for successful placement are counted.
Measured: During the insertion of i-gel or LMA protector
Insertion time
Insertion time is defined as the time from picking up the device to confirming successful placement (the appearance of the ETCO2 on the monitor screen).
Measured: During the insertion of i-gel or LMA protector
Ease of insertion
Ease of insertion is defined as follows. Easy: requiring no additional maneuver, fair: requiring 1 additional maneuver, difficult: requiring more than 1 additional maneuver.
Measured: During the insertion of i-gel or LMA protector
Ease of gastric tube insertion
Ease of garstic tube insertion is assessed as follows; easy, difficult, impossible.
Measured: At 25 min after the insertion of i-gel or LMA protector
The accuracy of insertion location of the device in the oropharyngeal space
After insertion of the device, the insertion location is assessed using a fiberoptic bronchoscope; 4, only the vocal cords seen; 3, vocal cords and posterior part of the epiglottis seen; 2, vocal cords and anterior part of the epiglottis seen; 1, vocal cords not seen, but adequate ventilation.
Measured: At 15 min after the insertion of i-gel or LMA protector
Blood staining on the i-gel or LMA protector
After removal of the device, the presence of blood staining on the device is checked.
Measured: Immediately after removal of i-gel or LMA protector
The incidence and severity of postoperative sore throat
Postoperative sore throat is assessed using a numerical rating scale (0-100 point).
Measured: At 1 and 24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 May 2017
- Primary completion19 Jan 2018
- Study completion20 Jan 2018
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 Mechanical VentilationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, M.D., Ph.D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078517
- Sponsor's protocol ID
- 20170104
- Status last verified
- Feb 2018
- First submitted
- 4 Jan 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang JE, Kim H, Lee JM, Min SW, Won D, Jun K, Hwang JY. A prospective, randomized comparison of the LMA-protector and i-gel in paralyzed, anesthetized patients. BMC Anesthesiol. 2019 Jul 4;19(1):118. doi: 10.1186/s12871-019-0785-8.
PubMed 31272379
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the LMA Protector and the I-gel in Anesthetized Patients.
- ClinicalTrials.gov ID
- NCT03078517
- Acronym / sponsor ID
- 20170104
- Conditions
- Mechanical Ventilation
- Keywords
- I-gel, Laryngeal mask airway protector
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 13 Mar 2017 (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.
Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-gel group | Active comparator | Device: I-gelAfter the induction of anesthesia, I-gel is inserted into the oropharyngeal space. |
| LMA protector group | Experimental | Device: Laryngeal mask airway protectorAfter the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Requirement for mechanical ventilation under general anesthesia
Key exclusion criteria (7 listed)
- Surgical position other than supine position
- Tumors or anatomical abnormalities in the upper airway
- Known or predicted difficult airway
- Body mass index > 30 kg/m2
- Required postoperative mechanical ventilation
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-gelAfter the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve. | Device | I-gel group |
| Laryngeal mask airway protectorAfter the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated. | Device | LMA protector group |
Primary outcome
Oropharyngeal airway leak pressure
Time frame: At 5 min after the insertion of i-gel or LMA protector
Oropharyngeal airway leak pressure is measured by closing the expiratory valve of the circle system at a fresh gas flow of 3 L/min and observing the airway pressure at equilibrium.
7 secondary outcomes
Number of insertion attempt for the successful placement
Time frame: During the insertion of i-gel or LMA protector
Insertion time
Time frame: During the insertion of i-gel or LMA protector
Ease of insertion
Time frame: During the insertion of i-gel or LMA protector
Ease of gastric tube insertion
Time frame: At 25 min after the insertion of i-gel or LMA protector
The accuracy of insertion location of the device in the oropharyngeal space
Time frame: At 15 min after the insertion of i-gel or LMA protector
Blood staining on the i-gel or LMA protector
Time frame: Immediately after removal of i-gel or LMA protector
The incidence and severity of postoperative sore throat
Time frame: At 1 and 24 h after 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 5 Feb 2018.
- Derived from this study: PubMed 31272379Chang JE, Kim H, Lee JM, Min SW, Won D, Jun K, Hwang JY. A prospective, randomized comparison of the LMA-protector and i-gel in paralyzed, anesthetized patients. BMC Anesthesiol. 2019 Jul 4;19(1):118. doi: 10.1186/s12871-019-0785-8.
- 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.
Jin-Young Hwang, M.D., Ph.D. principal investigator
SMG-SNU Boramae Medical Center
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 and Laryngeal mask airway protector in people with Mechanical Ventilation, run by SMG-SNU Boramae Medical Center 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 7 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 5 Feb 2018. 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?
Oropharyngeal airway leak pressure (time frame: At 5 min after the insertion of i-gel or LMA protector). 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 NCT03078517, 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 5 Feb 2018.