Intubation ComplicationNCT03102255
The Effect of 'Sniffing Position & Nasal Tip Lifting' in Nasotracheal Intubation
A study testing Sniffing position and Nasal tip lifting in people with Intubation Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this prospective randomized study is to compare the effect of nasal tip lifting during nasotracheal intubation. The question the investigators are trying to answer is: If the nasal tip is tilted, will the E-tube be more likely to enter the lower passage during nasal intubation? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Sniffing position and Nasal tip lifting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2016to 21 Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who need to nasotracheal intubation for surgery.
Who cannot join
- Who doesn't agree to enroll.
- Who has severe nasal deformities.
- Who has a problem to make sniffing position or nasal tip lifting
- Who has severe nasal bleeding history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 'Sniffing Position & Nasal Tip Lifting' on the Pathway of Tracheal Tube in Nasal Cavity During Nasotracheal Intubation
The goal of this prospective randomized study is to compare the effect of nasal tip lifting during nasotracheal intubation.
The question the investigators are trying to answer is: If the nasal tip is tilted, will the E-tube be more likely to enter the lower passage during nasal intubation?
Read the detailed description
There are three nasal turbinates inside the nasal cavities. Each nasal cavity is divided into four spaces from these nasal turbinates, but the two spaces separated by the upper nasal turbinate are too narrow to be clinically meaningful. So when performing nasotracheal intubation, the tube enters one of the two spaces in low part divided into the lower turbinate. The middle turbinate, unlike others, a large number of blood vessels and nerves are distributed. Therefore, less hemorrhage might occurs when the tracheal tube enters into the lower pathway below the lower turbinate because the tube would not scratching the middle turbinate.
The hypothesis of this study is that the method 'sniffing position and nasal tip lifting' increases possibility to enter into lower pathway when the tube enters the nasal cavity. The purpose of a present study was to investigate the effect of 'sniffing position \& nose' on the intranasal route of the tube.
- Conditions
- Intubation Complication
- Being tested
- Sniffing position, Nasal tip lifting
- Keywords
- Nasotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sniffing positionProcedure or surgery
All procedure is done under sniffing position.
Nasal tip liftingProcedure or surgery
Before inserting the endotracheal tube to patient's nose, the researcher lift up the nose tip.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Performed nasotracheal intubation as usual. Sniffing position but doesn't lift a nasal tip. Receives: Procedure: Sniffing position |
| Nasal tip lifting | Experimental | Performed sniffing position and nasal tip lifting while the endotracheal tube insert patient's nasal cavity. Receives: Procedure: Sniffing position; Procedure: Nasal tip lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with nasal endotraheal tube in the lowest nasal pathway.
After the endotracheal intubation is completed, the experimenter confirms by a fiberoptic bronchoscope which path the endotracheal tube is located.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Nasal bleeding
After nasotracheal intubation, the researcher confirm there is nasal bleeding or not. And if bleeding observed, the experimenter would check the amount.
Measured: Through study completion, an average of 1 year
Intubation time
Check the time from initiation of insertion of E-tube to finish passing nasal path and to finish intubation.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Aug 2016
- Primary completion5 Jun 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Boramae Hospital
- Investigators
- Jung-Man Lee, M.D.,PhD, Study director, Seoul National University Boramae Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102255
- Sponsor's protocol ID
- 20160707/26-2016-90/072
- Status last verified
- Oct 2017
- First submitted
- 20 Mar 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed-Nusrath A, Tong JL, Smith JE. Pathways through the nose for nasal intubation: a comparison of three endotracheal tubes. Br J Anaesth. 2008 Feb;100(2):269-74. doi: 10.1093/bja/aem350. Epub 2007 Dec 14.
PubMed 18083994Patiar S, Ho EC, Herdman RC. Partial middle turbinectomy by nasotracheal intubation. Ear Nose Throat J. 2006 Jun;85(6):380, 382-3.
PubMed 16866113Williams AR, Burt N, Warren T. Accidental middle turbinectomy: a complication of nasal intubation. Anesthesiology. 1999 Jun;90(6):1782-4. doi: 10.1097/00000542-199906000-00039. No abstract available.
PubMed 10360881Dost P, Armbruster W. Nasal turbinate dislocation caused by nasotracheal intubation. Acta Anaesthesiol Scand. 1997 Jun;41(6):795-6. doi: 10.1111/j.1399-6576.1997.tb04787.x.
PubMed 9241346Scamman FL, Babin RW. An unusual complication of nasotracheal intubation. Anesthesiology. 1983 Oct;59(4):352-3. doi: 10.1097/00000542-198310000-00016. No abstract available.
PubMed 6614546Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Choi S, Min SW. Influence of Nasal Tip Lifting on the Incidence of the Tracheal Tube Pathway Passing Through the Nostril During Nasotracheal Intubation: A Randomized Controlled Trial. Anesth Analg. 2018 Dec;127(6):1421-1426. doi: 10.1213/ANE.0000000000003673.
PubMed 30044295
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 'Sniffing Position & Nasal Tip Lifting' on the Pathway of Tracheal Tube in Nasal Cavity During Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT03102255
- Acronym / sponsor ID
- 20160707/26-2016-90/072
- Conditions
- Intubation Complication
- Keywords
- Nasotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 5 Apr 2017 (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 goal of this prospective randomized study is to compare the effect of nasal tip lifting during nasotracheal intubation.
The question the investigators are trying to answer is: If the nasal tip is tilted, will the E-tube be more likely to enter the lower passage during nasal intubation?
Detailed description
There are three nasal turbinates inside the nasal cavities. Each nasal cavity is divided into four spaces from these nasal turbinates, but the two spaces separated by the upper nasal turbinate are too narrow to be clinically meaningful. So when performing nasotracheal intubation, the tube enters one of the two spaces in low part divided into the lower turbinate. The middle turbinate, unlike others, a large number of blood vessels and nerves are distributed. Therefore, less hemorrhage might occurs when the tracheal tube enters into the lower pathway below the lower turbinate because the tube would not scratching the middle turbinate.
The hypothesis of this study is that the method 'sniffing position and nasal tip lifting' increases possibility to enter into lower pathway when the tube enters the nasal cavity. The purpose of a present study was to investigate the effect of 'sniffing position \& nose' on the intranasal route of the tube.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: Sniffing positionPerformed nasotracheal intubation as usual. Sniffing position but doesn't lift a nasal tip. |
| Nasal tip lifting | Experimental | Procedure: Sniffing position, Procedure: Nasal tip liftingPerformed sniffing position and nasal tip lifting while the endotracheal tube insert patient's nasal cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who need to nasotracheal intubation for surgery.
Key exclusion criteria (4 listed)
- Who doesn't agree to enroll.
- Who has severe nasal deformities.
- Who has a problem to make sniffing position or nasal tip lifting
- Who has severe nasal bleeding history.
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 |
|---|---|---|
| Sniffing positionAll procedure is done under sniffing position. | Procedure or surgery | Conventional, Nasal tip lifting |
| Nasal tip liftingBefore inserting the endotracheal tube to patient's nose, the researcher lift up the nose tip. | Procedure or surgery | Nasal tip lifting |
Primary outcome
Number of patients with nasal endotraheal tube in the lowest nasal pathway.
Time frame: Through study completion, an average of 1 year
After the endotracheal intubation is completed, the experimenter confirms by a fiberoptic bronchoscope which path the endotracheal tube is located.
2 secondary outcomes
Nasal bleeding
Time frame: Through study completion, an average of 1 year
Intubation time
Time frame: Through study completion, an average of 1 year
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 13 Oct 2017.
- Background: PubMed 18083994Ahmed-Nusrath A, Tong JL, Smith JE. Pathways through the nose for nasal intubation: a comparison of three endotracheal tubes. Br J Anaesth. 2008 Feb;100(2):269-74. doi: 10.1093/bja/aem350. Epub 2007 Dec 14.
- Background: PubMed 16866113Patiar S, Ho EC, Herdman RC. Partial middle turbinectomy by nasotracheal intubation. Ear Nose Throat J. 2006 Jun;85(6):380, 382-3.
- Background: PubMed 10360881Williams AR, Burt N, Warren T. Accidental middle turbinectomy: a complication of nasal intubation. Anesthesiology. 1999 Jun;90(6):1782-4. doi: 10.1097/00000542-199906000-00039. No abstract available.
- Background: PubMed 9241346Dost P, Armbruster W. Nasal turbinate dislocation caused by nasotracheal intubation. Acta Anaesthesiol Scand. 1997 Jun;41(6):795-6. doi: 10.1111/j.1399-6576.1997.tb04787.x.
- Background: PubMed 6614546Scamman FL, Babin RW. An unusual complication of nasotracheal intubation. Anesthesiology. 1983 Oct;59(4):352-3. doi: 10.1097/00000542-198310000-00016. No abstract available.
- Derived from this study: PubMed 30044295Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Choi S, Min SW. Influence of Nasal Tip Lifting on the Incidence of the Tracheal Tube Pathway Passing Through the Nostril During Nasotracheal Intubation: A Randomized Controlled Trial. Anesth Analg. 2018 Dec;127(6):1421-1426. doi: 10.1213/ANE.0000000000003673.
- 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.
Jung-Man Lee, M.D.,PhD study director
Seoul National University Boramae Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sniffing position and Nasal tip lifting in people with Intubation Complication, run by Seoul National University Hospital 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 4 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 13 Oct 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?
Number of patients with nasal endotraheal tube in the lowest nasal pathway. (time frame: Through study completion, an average of 1 year). 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 NCT03102255, which also lists 6 linked publications.
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 13 Oct 2017.