Nasotracheal IntubationNCT04499222
Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes
A study testing Portex and Mallinckrodt in people with Nasotracheal Intubation, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal tube (PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom], Mallinckrodt TaperGuard [Covidien, Ireland]) depth in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nasotracheal Intubation
- What is being tested?
- Portex and Mallinckrodt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2020to May 2025
- 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
- 1. Adult patients who undergoes elective surgery under general anesthesia with nasotracheal intubation
Who cannot join
- Patients under 20 years old
- Patients with ASA class IV or higher
- Pregnant women
- Patients receiving emergency surgery
- Patients who have nasal disease or who undergo nose surgery because of nasal disease
- Patient with craniofacial anomaly
Show all 9Show fewer
- Patients with impaired cervical motion
- Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
- Patients who refused the clinical trial Patients with dementia or cognitive impairment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul
Hyun Joo Kim, MD, 82-2-2224-1389, JJOLLONG@yuhs.ac
About this study
The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal tube (PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom], Mallinckrodt TaperGuard [Covidien, Ireland]) depth in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral neck position.
- Conditions
- Nasotracheal Intubation
- Being tested
- Portex, Mallinckrodt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PortexDevice
nasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube.
MallinckrodtDevice
nasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Portex | Experimental | usage of PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube Receives: Device: Portex |
| Mallinckrodt | Active comparator | usage of Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube Receives: Device: Mallinckrodt |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position
- whether the tube tip is located above the carina in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).
- the distance from the carina to the tube tip in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).
Measured: 1 minute after nasotracheal intubation
Secondary outcomes (2)
The adequacy of nasotracheal tube cuff location in extended and flexed neck position
whether the tube cuff is located below the vocal cords in extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords in neutral neck position.
Measured: 1 minute after nasotracheal intubation
The adequacy of nasotracheal tube length
whether the tube cuff cannot be located 3cm below the vocal cords owing to short length of nasotracheal tube.
Measured: 1 minute after nasotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasotracheal IntubationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT04499222
- Sponsor's protocol ID
- 4-2020-0654
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2020
- Last updated
- 5 Aug 2020
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes
- ClinicalTrials.gov ID
- NCT04499222
- Acronym / sponsor ID
- 4-2020-0654
- Conditions
- Nasotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 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.
The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal tube (PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom], Mallinckrodt TaperGuard [Covidien, Ireland]) depth in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral neck position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portex | Experimental | Device: Portexusage of PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube |
| Mallinckrodt | Active comparator | Device: Mallinckrodtusage of Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult patients who undergoes elective surgery under general anesthesia with nasotracheal intubation
Key exclusion criteria (9 listed)
- Patients under 20 years old
- Patients with ASA class IV or higher
- Pregnant women
- Patients receiving emergency surgery
- Patients who have nasal disease or who undergo nose surgery because of nasal disease
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 |
|---|---|---|
| Portexnasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube. | Device | Portex |
| Mallinckrodtnasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube. | Device | Mallinckrodt |
Primary outcome
The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position
Time frame: 1 minute after nasotracheal intubation
1. whether the tube tip is located above the carina in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position). 2. the distance from the carina to the tube tip in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).
2 secondary outcomes
The adequacy of nasotracheal tube cuff location in extended and flexed neck position
Time frame: 1 minute after nasotracheal intubation
The adequacy of nasotracheal tube length
Time frame: 1 minute after nasotracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Nasotracheal Intubation
Not yet recruiting
ASIGN Trial- Angulated Versus Standard Video-laryngoscope Blade in Nasal Intubation
Nasal Intubation
Recruiting
Comparison of Awake Tracheal Intubation Methods
Airway Management Assessment, Awake Endotracheal Intubation
Recruiting
Fibrescope vs Videolaryngoscope for Nasotracheal Intubation
No Disease
Recruiting
Nostril Side on Epistaxis
Nasotracheal Intubation
Recruiting
The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy
Hypoxia, Pulmonary Nodule
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 Portex and Mallinckrodt in people with Nasotracheal Intubation, 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 9 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 5 Aug 2020. 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 (82-2-2224-1389, JJOLLONG@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position (time frame: 1 minute after nasotracheal intubation). 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 5 Aug 2020.