Anesthesia, GeneralNCT03962374
The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope
A study testing Frova and Stylet in people with Anesthesia, General, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Frova and Stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jun 2022to Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery.
- 2. Patients who have one of the predictors of difficult intubation such as Mallampati classification 3 or 4, limited the movement of the neck, body mass index less than 35 kg/m2, a distance from the tip of the chin to the thyroid cartilage of less than 6.5 cm, a interincisor distance less than 3.5 cm, inability to protrude of lower incisors over the upper incisors, or a diagnosis of obstructive sleep apnea.
Who cannot join
- 1. Patients receiving emergency surgery
- 2. Pregnant women
- 3. Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery
- 4. Patients who have a history of ankylosing spondylitis or have a large tumor of 4 cm or more on the tongue and need an awake intubation
- 5. Patients who are at risk of vomiting due to not fasting time
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
Hyun Joo Kim, M.D., Ph.D., 82-2-2224-1389, JJOLLONG@yuhs.ac
About this study
The purpose of this study is to compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope.
- Conditions
- Anesthesia, General
- Being tested
- Frova, Stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrovaDevice
Frova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.
StyletDevice
Stylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Frova | Experimental | Frova will be used to facilitate the endotracheal intubation. Receives: Device: Frova |
| Stylet | Active comparator | Stylet will be used to facilitate the endotracheal intubation. Receives: Device: Stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of first attempt of endotracheal intubation
The endotracheal intubation will be attempted using stylet or frova according to the randomized group. The success or failure of the attempt will be recorded.
Measured: for 10 minutes during anesthetic induction
Secondary outcomes (1)
time for endotracheal intubation
Time will be measured from when the blades of the videolaryngoscope pass through the patient's mouth until the end-tidal CO2 is detected.
Measured: for 10 minutes during anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start21 Jun 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962374
- Sponsor's protocol ID
- 4-2019-0289
- Status last verified
- Dec 2022
- First submitted
- 22 May 2019
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope
- ClinicalTrials.gov ID
- NCT03962374
- Acronym / sponsor ID
- 4-2019-0289
- Conditions
- Anesthesia, General
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 May 2019 (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.
The purpose of this study is to compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frova | Experimental | Device: FrovaFrova will be used to facilitate the endotracheal intubation. |
| Stylet | Active comparator | Device: StyletStylet will be used to facilitate the endotracheal intubation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery.
- 2. Patients who have one of the predictors of difficult intubation such as Mallampati classification 3 or 4, limited the movement of the neck, body mass index less than 35 kg/m2, a distance from the tip of the chin to the thyroid cartilage of less than 6.5 cm, a interincisor distance less than 3.5 cm, inability to protrude of lower incisors over the upper incisors, or a diagnosis of obstructive sleep apnea.
Key exclusion criteria (5 listed)
- 1. Patients receiving emergency surgery
- 2. Pregnant women
- 3. Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery
- 4. Patients who have a history of ankylosing spondylitis or have a large tumor of 4 cm or more on the tongue and need an awake intubation
- 5. Patients who are at risk of vomiting due to not fasting time
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 |
|---|---|---|
| FrovaFrova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed. | Device | Frova |
| StyletStylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed. | Device | Stylet |
Primary outcome
Success rate of first attempt of endotracheal intubation
Time frame: for 10 minutes during anesthetic induction
The endotracheal intubation will be attempted using stylet or frova according to the randomized group. The success or failure of the attempt will be recorded.
1 secondary outcome
time for endotracheal intubation
Time frame: for 10 minutes during anesthetic induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frova and Stylet in people with Anesthesia, General, 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Joo Kim, MD, Ph.D (02-2224-1389, jjollong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of first attempt of endotracheal intubation (time frame: for 10 minutes during anesthetic induction). 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 6 Dec 2022.