Intubation;DifficultNCT03377114
Effect of Head Tilting During Nasotracheal Intubation
A study testing Neutral and Head tilting in people with Intubation;Difficult, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this prospective randomized controlled study is to investigate the effect of head tilting on tracheal tube passing during nasotracheal intubation. The question which the investigators are trying to answer is: If patient's neck is extented on inserting tracheal tube via nostril, will the E-tube be more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Neutral and Head tilting
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2017to 13 Jul 2018
- 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 a problem to head tilting position such as C-spine injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Head Tilting on the Passing of Tracheal Tube Through Nasopharynx During Nasotracheal Intubation
The goal of this prospective randomized controlled study is to investigate the effect of head tilting on tracheal tube passing during nasotracheal intubation.
The question which the investigators are trying to answer is: If patient's neck is extented on inserting tracheal tube via nostril, will the E-tube be more easily to pass through nasopharynx to oropharynx without trapping?
Read the detailed description
For nasotracheal intubation, clinicians do sometimes experience tube trapping at naso/oro-pharyngeal tissue. Application of force to overcome resistance can cause tissue injury leading to bleeding, which can disturb tracheal intubation.
The hypothesis of this study is that the method of 'head tilting' can help easy passing of tracheal tube at naso/oro-pharyngeal pathway without trapping in nasotracheal intubation. The purpose of the present study is to investigate the effect of 'head tilting' on the incidence of trapping of tracheal tube at naso/oro-pharynx when tracheal tube is being advanced into oropharynx via nostril during nasotracheal intubation.
- Conditions
- Intubation;Difficult
- Being tested
- Neutral, Head tilting
- Keywords
- Nasotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeutralProcedure or surgery
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head and neck in neutral position.
Head tiltingProcedure or surgery
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head in head-tilting position.
| Study group | Role | What they receive |
|---|---|---|
| Neutral | Active comparator | When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head and neck in neutral position. Receives: Procedure: Neutral |
| Head tilting | Experimental | When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head in head-tilting position. Receives: Procedure: Head tilting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tube trapping
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians feel resistance in advancement.
Measured: During nasotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start14 Dec 2017
- Primary completion29 Jun 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Hospital
- Investigators
- Jung-Man Lee, M.D.,PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377114
- Sponsor's protocol ID
- 16-2017-64
- Status last verified
- Sep 2018
- First submitted
- 13 Dec 2017
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paul M, Dueck M, Kampe S, Petzke F, Ladra A. Intracranial placement of a nasotracheal tube after transnasal trans-sphenoidal surgery. Br J Anaesth. 2003 Oct;91(4):601-4. doi: 10.1093/bja/aeg203.
PubMed 14504169Bozdogan N, Sener M, Yavuz H, Yilmazer C, Turkoz A, Arslan G. Retropharyngeal submucosal dissection due to nasotracheal intubation. B-ENT. 2008;4(3):179-81.
PubMed 18949966Ersoy B, Gursoy T, Celebiler O, Umuroglu T. A complication of nasotracheal intubation after mandibular subcondylar fracture. J Craniofac Surg. 2011 Jul;22(4):1527-9. doi: 10.1097/SCS.0b013e31821d4e04.
PubMed 21778857Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.
PubMed 31421677
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Tilting on the Passing of Tracheal Tube Through Nasopharynx During Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT03377114
- Acronym / sponsor ID
- 16-2017-64
- Conditions
- Intubation;Difficult
- Keywords
- Nasotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 19 Dec 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 controlled study is to investigate the effect of head tilting on tracheal tube passing during nasotracheal intubation.
The question which the investigators are trying to answer is: If patient's neck is extented on inserting tracheal tube via nostril, will the E-tube be more easily to pass through nasopharynx to oropharynx without trapping?
Detailed description
For nasotracheal intubation, clinicians do sometimes experience tube trapping at naso/oro-pharyngeal tissue. Application of force to overcome resistance can cause tissue injury leading to bleeding, which can disturb tracheal intubation.
The hypothesis of this study is that the method of 'head tilting' can help easy passing of tracheal tube at naso/oro-pharyngeal pathway without trapping in nasotracheal intubation. The purpose of the present study is to investigate the effect of 'head tilting' on the incidence of trapping of tracheal tube at naso/oro-pharynx when tracheal tube is being advanced into oropharynx via nostril during nasotracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral | Active comparator | Procedure: NeutralWhen inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head and neck in neutral position. |
| Head tilting | Experimental | Procedure: Head tiltingWhen inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head in head-tilting position. |
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 (2 listed)
- Who doesn't agree to enroll
- Who has a problem to head tilting position such as C-spine injury.
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 |
|---|---|---|
| NeutralWhen inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head and neck in neutral position. | Procedure or surgery | Neutral |
| Head tiltingWhen inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head in head-tilting position. | Procedure or surgery | Head tilting |
Primary outcome
Tube trapping
Time frame: During nasotracheal intubation
When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians feel resistance in advancement.
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 17 Sep 2018.
- Background: PubMed 14504169Paul M, Dueck M, Kampe S, Petzke F, Ladra A. Intracranial placement of a nasotracheal tube after transnasal trans-sphenoidal surgery. Br J Anaesth. 2003 Oct;91(4):601-4. doi: 10.1093/bja/aeg203.
- Background: PubMed 18949966Bozdogan N, Sener M, Yavuz H, Yilmazer C, Turkoz A, Arslan G. Retropharyngeal submucosal dissection due to nasotracheal intubation. B-ENT. 2008;4(3):179-81.
- Background: PubMed 21778857Ersoy B, Gursoy T, Celebiler O, Umuroglu T. A complication of nasotracheal intubation after mandibular subcondylar fracture. J Craniofac Surg. 2011 Jul;22(4):1527-9. doi: 10.1097/SCS.0b013e31821d4e04.
- Derived from this study: PubMed 31421677Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.
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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 principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral and Head tilting in people with Intubation;Difficult, 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 2 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 17 Sep 2018. 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?
Tube trapping (time frame: During nasotracheal intubation). 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 NCT03377114, which also lists 4 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 17 Sep 2018.