Laryngeal Mask AirwayNCT04520555
Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture
A study testing Laryngeal mask airway and Endotracheal tube in people with Laryngeal Mask Airway, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
In surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. However, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- Laryngeal mask airway and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2020to 27 Jan 2022
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture
Who cannot join
- Patients with high risk of aspiration, patients who anticipated difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Recovery Profiles Between Flexible Laryngeal Mask Airway and Tracheal Intubation in Nasal Bone Fracture
In surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. However, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. The aim of study is to evaluate the efficacy of the laryngeal mask airway regarding recovery profiles and airway complications, compared to tracheal intubation.
- Conditions
- Laryngeal Mask Airway
- Being tested
- Laryngeal mask airway, Endotracheal tube
- Keywords
- Laryngeal mask airway, Intubation, nasal bone fracture, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask airwayDevice
Also called LMA Flexible,Teleflex Co., Westmeath, Ireland
LMA Flexible is a supraglottic airway device, which can be moved out of the surgical field without displacement of the cuff, or loss of seal for the anesthetist
Endotracheal tubeDevice
Also called Portex, Smiths Medical International Ltd., South East England, United Kingdom
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal mask airway group | Experimental | Flexible laryngeal mask airway is inserted for general anesthesia Receives: Device: Laryngeal mask airway |
| intubation group | Active comparator | Endotracheal intubation was performed for general anesthesia Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough during extubation
Grade of cough during periextubation periods (0=no cough, 1=single cough, 2=more than one episode of non-sustained cough, 3=sustained and repetitive cough with head lift)
Measured: From end of surgery to extubation
Secondary outcomes (11)
Adequate tidal volume during mechanical ventilation
Tidal volume (ml)
Measured: From insertion of airway device to extubation
Adequate ventilation during mechanical ventilation
end-tidal carbon dioxide
Measured: From insertion of airway device to extubation
Airway pressure during mechanical ventilation
peak and mean airway pressure
Measured: From insertion of airway device to extubation
Changes of heart rate
Heart rate
Measured: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Changes of blood pressure
mean blood pressure
Measured: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Changes of saturation
peripheral saturation
Measured: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Number of Participants with blood contamination at vocal cord and distal trachea
Blood contamination was examined using fibrobronchoscope.
Measured: Between the end of surgery and extubation
Device blood contamination
0=no contamination, 1=external contamination of the tube, 2=some soilage of the inner surface of the tube, 3=frank coating of the inner surface of the tube
Measured: At airway device removal
Number of Participants with airway complications after extubation
laryngospasm, hypoventilation (respiratory rate <8/minutes), desaturation (peripheral pulse oximetry saturation <95%)
Measured: From extubation to 5 minutes after extubation
Time to eye opening and time to extubation
Time in seconds from anesthetic discontinuation to eye opening at verbal commend and time in seconds from anesthetic discontinuation to extubation
Measured: From anesthetic discontinuation to eye opening and extubation
Number of Participants with postoperative airway complications
Sore throat, hoarseness, dysphagia, and nausea and vomiting
Measured: 30 minutes after surgery and postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start13 Jul 2020
- Primary completion26 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- JongYeop Kim, M.D.,Ph.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520555
- Sponsor's protocol ID
- AJIRB-MED-OBS-20-081
- Status last verified
- Jul 2022
- First submitted
- 12 Aug 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Recovery Profiles Between Flexible Laryngeal Mask Airway and Tracheal Intubation in Nasal Bone Fracture
- ClinicalTrials.gov ID
- NCT04520555
- Acronym / sponsor ID
- AJIRB-MED-OBS-20-081
- Conditions
- Laryngeal Mask Airway
- Keywords
- Laryngeal mask airway, Intubation, nasal bone fracture, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 20 Aug 2020 (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 surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. However, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. The aim of study is to evaluate the efficacy of the laryngeal mask airway regarding recovery profiles and airway complications, compared to tracheal intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal mask airway group | Experimental | Device: Laryngeal mask airwayFlexible laryngeal mask airway is inserted for general anesthesia |
| intubation group | Active comparator | Device: Endotracheal tubeEndotracheal intubation was performed for general anesthesia |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture
Key exclusion criteria (1 listed)
- Patients with high risk of aspiration, patients who anticipated difficult airway
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 |
|---|---|---|
| Laryngeal mask airwayAlso: LMA Flexible,Teleflex Co., Westmeath, IrelandLMA Flexible is a supraglottic airway device, which can be moved out of the surgical field without displacement of the cuff, or loss of seal for the anesthetist | Device | Laryngeal mask airway group |
| Endotracheal tubeAlso: Portex, Smiths Medical International Ltd., South East England, United KingdomEndotracheal tube is a plain tube, which is most commonly used in general anesthesia. | Device | intubation group |
Primary outcome
cough during extubation
Time frame: From end of surgery to extubation
Grade of cough during periextubation periods (0=no cough, 1=single cough, 2=more than one episode of non-sustained cough, 3=sustained and repetitive cough with head lift)
11 secondary outcomes
Adequate tidal volume during mechanical ventilation
Time frame: From insertion of airway device to extubation
Adequate ventilation during mechanical ventilation
Time frame: From insertion of airway device to extubation
Airway pressure during mechanical ventilation
Time frame: From insertion of airway device to extubation
Changes of heart rate
Time frame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Changes of blood pressure
Time frame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Changes of saturation
Time frame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Number of Participants with blood contamination at vocal cord and distal trachea
Time frame: Between the end of surgery and extubation
Device blood contamination
Time frame: At airway device removal
Number of Participants with airway complications after extubation
Time frame: From extubation to 5 minutes after extubation
Time to eye opening and time to extubation
Time frame: From anesthetic discontinuation to eye opening and extubation
Number of Participants with postoperative airway complications
Time frame: 30 minutes after surgery and postoperative 1 day
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 20 Jul 2022.
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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.
JongYeop Kim, M.D.,Ph.D. 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 Laryngeal mask airway and Endotracheal tube in people with Laryngeal Mask Airway, 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 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 20 Jul 2022. 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?
cough during extubation (time frame: From end of surgery to extubation). 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 20 Jul 2022.