Intubation;DifficultNCT03645174
Long Endotracheal Tube vs. Aintree Intubating Catheter for Fiberoptic-guided Intubation in Manikin
A study testing Using long tube and Aintree catheter in people with Intubation;Difficult, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
In difficult airway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option. Aintree catheter is a device to help change LMA to endotracheal tube, but it needs complex and multiple process. Long endotracheal tube can solve this problem of Aintree catheter. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Using long tube and Aintree catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2018to 15 Jan 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Residents of Anesthesiology
- Who has less than 10 times of experience of fiberoptic intubation
Who cannot join
- Who has more than 10 times of experience of fiberoptic intubation
- Who deny participating in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16377
About this study
Official title: Fiberoptic-guided Endotracheal Intubation Through Laryngeal Mask Airway in Manikin; Long Endotracheal Tube vs. Aintree Intubating Catheter
In difficult airway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option. Aintree catheter is a device to help change LMA to endotracheal tube, but it needs complex and multiple process. Long endotracheal tube can solve this problem of Aintree catheter. The purpose of this study is proving the efficacy of long endotracheal tube compared to Aintree cathter in fiberoptic-guided intubation through LMA.
Read the detailed description
In difficult aiway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option according to Difficult intubation guidelines. First, insert LMA and insert fiberoptic through LMA. Second, insert endotracheal tube using fiberoptic as a guide. This process has several problem. Removal of LMA is impossible, so there is a risk of dislodging of endotracheal tube.
Aintree catheter is developed to this problem. Insert Aintree catheter through LMA using fiberoptic, and remove LMA, finally insert endotracheal tube throug Aintree catheter. But the problem of this method is that the whole process is complex and takes long time. And there is a risk of impeding of endotracheal tube at glottis level because the difference of diameters between endotracheal tube and aintree catheter.
Long endotracheal tube could solve the problems mentioned above. Through LMA, insert endotracheal tube using fiberoptic as a guide. Tube is long enough to remove LMA without a risk of dislodging. And after removal of LMA, tube can be cut for optimizing length.
So the purpose of this study is comparing the efficacy of Aintree catheter method and Long tube method in manikin.
- Conditions
- Intubation;Difficult
- Being tested
- Using long tube, Aintree catheter
- Keywords
- intubation, Aintree, Laryngeal mask airway, fiberoptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using long tubeDevice
Fiberoptic-guided intubation through LMA, using long tube
Aintree catheterDevice
Fiberoptic-guided intubation through LMA, using Aintree catheter
| Study group | Role | What they receive |
|---|---|---|
| Aintree catheter | Active comparator | Fiberoptic-guided intubation through LMA, using Aintree catheter Receives: Device: Aintree catheter |
| Long tube | Experimental | Fiberoptic-guided intubation through LMA, using long tube Receives: Device: Using long tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
from entry of fiberoptic at LMA to Ambu bagging
Measured: 3 minutes
Secondary outcomes (2)
Success rate
Failure is esophageal intubation or disloding of endotracheal tube in any process
Measured: 5 minutes
Difficulty score
Subjective score using numeric rating scale (1; extremely easy - 10; extremely difficult)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion15 Jan 2019
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 Intubation;DifficultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Manikin model Intubators are residents of Anesthesiology
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645174
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-226
- Status last verified
- Mar 2019
- First submitted
- 22 Aug 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only for personally requested
Publications
Chae YJ, Lee H, Jun B, Yi IK. Conversion of I-gel to definitive airway in a cervical immobilized manikin: Aintree intubation catheter vs long endotracheal tube. BMC Anesthesiol. 2020 Jun 18;20(1):152. doi: 10.1186/s12871-020-01069-9.
PubMed 32552828
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiberoptic-guided Endotracheal Intubation Through Laryngeal Mask Airway in Manikin; Long Endotracheal Tube vs. Aintree Intubating Catheter
- ClinicalTrials.gov ID
- NCT03645174
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-226
- Conditions
- Intubation;Difficult
- Keywords
- intubation, Aintree, Laryngeal mask airway, fiberoptic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 24 Aug 2018 (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.
In difficult airway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option. Aintree catheter is a device to help change LMA to endotracheal tube, but it needs complex and multiple process. Long endotracheal tube can solve this problem of Aintree catheter. The purpose of this study is proving the efficacy of long endotracheal tube compared to Aintree cathter in fiberoptic-guided intubation through LMA.
Detailed description
In difficult aiway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option according to Difficult intubation guidelines. First, insert LMA and insert fiberoptic through LMA. Second, insert endotracheal tube using fiberoptic as a guide. This process has several problem. Removal of LMA is impossible, so there is a risk of dislodging of endotracheal tube.
Aintree catheter is developed to this problem. Insert Aintree catheter through LMA using fiberoptic, and remove LMA, finally insert endotracheal tube throug Aintree catheter. But the problem of this method is that the whole process is complex and takes long time. And there is a risk of impeding of endotracheal tube at glottis level because the difference of diameters between endotracheal tube and aintree catheter.
Long endotracheal tube could solve the problems mentioned above. Through LMA, insert endotracheal tube using fiberoptic as a guide. Tube is long enough to remove LMA without a risk of dislodging. And after removal of LMA, tube can be cut for optimizing length.
So the purpose of this study is comparing the efficacy of Aintree catheter method and Long tube method in manikin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Manikin model Intubators are residents of Anesthesiology
| Arm | Type | Receives |
|---|---|---|
| Aintree catheter | Active comparator | Device: Aintree catheterFiberoptic-guided intubation through LMA, using Aintree catheter |
| Long tube | Experimental | Device: Using long tubeFiberoptic-guided intubation through LMA, using long tube |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Residents of Anesthesiology
- Who has less than 10 times of experience of fiberoptic intubation
Key exclusion criteria (2 listed)
- Who has more than 10 times of experience of fiberoptic intubation
- Who deny participating in the study
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 |
|---|---|---|
| Using long tubeFiberoptic-guided intubation through LMA, using long tube | Device | Long tube |
| Aintree catheterFiberoptic-guided intubation through LMA, using Aintree catheter | Device | Aintree catheter |
Primary outcome
Intubation time
Time frame: 3 minutes
from entry of fiberoptic at LMA to Ambu bagging
2 secondary outcomes
Success rate
Time frame: 5 minutes
Difficulty score
Time frame: 5 minutes
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 Mar 2019.
- Derived from this study: PubMed 32552828Chae YJ, Lee H, Jun B, Yi IK. Conversion of I-gel to definitive airway in a cervical immobilized manikin: Aintree intubation catheter vs long endotracheal tube. BMC Anesthesiol. 2020 Jun 18;20(1):152. doi: 10.1186/s12871-020-01069-9.
- Individual participant dataSharing planned: No. only for personally requested
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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.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using long tube and Aintree catheter in people with Intubation;Difficult, run by Ajou University School of Medicine 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 2 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 Mar 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?
Intubation time (time frame: 3 minutes). 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 NCT03645174, 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 Mar 2019.