Nasotracheal IntubationNCT02876913
Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study
An observational study of Nasotracheal Intubation, run by Yonsei University at 1 site in South Korea.
Trial summary
The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Nasotracheal Intubation
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2016to 23 Jun 2017
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for nasotracheal intubation for general anesthesia
Who may be able to join
- Patients who are scheduled for nasotracheal intubation for general anesthesia
Who cannot join
- age < 20 years and age > 70 years
- ASA(American Society of Anesthesiologist) class III or more
- pregnancy
- emergency surgery
- nasal airway disease
- expected difficult intubation (difficult intubation history, Modified Mallampati score 4, mouth opening <2cm, facial anomaly)
- unstable teeth
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length from the nare to the carina and vocal cord are measured.
- Conditions
- Nasotracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group Nasotracheal Intubation | Patients who are scheduled for nasotracheal intubation for general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the inappropriate insertion of nasotracheal tube
the inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord
Measured: 5 minutes after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start24 Aug 2016
- Primary completion23 Jun 2017
- Study completion23 Jun 2017
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876913
- Sponsor's protocol ID
- 4-2016-0504
- Status last verified
- Sep 2017
- First submitted
- 16 Aug 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee B, Park WK, Yun SY, Kang S, Kim HJ. Insertion depth of nasotracheal tubes sized to fit the nostril: an observational study. J Int Med Res. 2019 Jan;47(1):235-243. doi: 10.1177/0300060518800105. Epub 2018 Dec 16.
PubMed 30556457
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study
- ClinicalTrials.gov ID
- NCT02876913
- Acronym / sponsor ID
- 4-2016-0504
- Conditions
- Nasotracheal Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 24 Aug 2016 (estimated)
- 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 nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length from the nare to the carina and vocal cord are measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Nasotracheal Intubation | – | –Patients who are scheduled for nasotracheal intubation for general anesthesia |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for nasotracheal intubation for general anesthesia
Key inclusion criteria (1 listed)
- Patients who are scheduled for nasotracheal intubation for general anesthesia
Key exclusion criteria (7 listed)
- age < 20 years and age > 70 years
- ASA(American Society of Anesthesiologist) class III or more
- pregnancy
- emergency surgery
- nasal airway disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of the inappropriate insertion of nasotracheal tube
Time frame: 5 minutes after induction of general anesthesia
the inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord
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 6 Sep 2017.
- Derived from this study: PubMed 30556457Lee B, Park WK, Yun SY, Kang S, Kim HJ. Insertion depth of nasotracheal tubes sized to fit the nostril: an observational study. J Int Med Res. 2019 Jan;47(1):235-243. doi: 10.1177/0300060518800105. Epub 2018 Dec 16.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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 6 Sep 2017. 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?
Proportion of the inappropriate insertion of nasotracheal tube (time frame: 5 minutes after induction of general anesthesia). 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 NCT02876913, 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 6 Sep 2017.