Computed Tomography-guided Nasotracheal IntubationNCT05525754
Computed Tomography-Guided Nasotracheal Intubation Procedure
An observational study of Computed Tomography-guided Nasotracheal Intubation and The Space Where the Tube Will be Passed in the Internal Nasal Valve Region, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Background: Nasotracheal intubation can lead to severe complications like epistaxis with excessive bleeding. The advancement difficulty of the tube faced during nasal intubation is one of the fundamental causes of this condition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Computed Tomography-guided Nasotracheal Intubation, The Space Where the Tube Will be Passed in the Internal Nasal Valve Region
- What is being tested?
- computed tomography-guided nasotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixty health volunteers who went orthognathic surgery
Who may be able to join
- Aged 18 to 65 who underwent bimaxillary orthognathic surgery
- defined as ASA (American Society of Anesthesiology) I or II
Who cannot join
- The lack of preoperative CT scans
- airways evaluated and considered difficult by the anesthesiologist
- airways assessed and considered not appropriate for right angle endotracheal (RAE) tube with7.0 mm internal diameter
- history of sinusitis or head trauma
- anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Computed Tomography-Guided Nasotracheal Intubation Procedure on Predicting Tube Advancement Difficulty and Preventing Epistaxis: A Prospective Case-control Study
Background: Nasotracheal intubation can lead to severe complications like epistaxis with excessive bleeding. The advancement difficulty of the tube faced during nasal intubation is one of the fundamental causes of this condition. The present study aimed to evaluate the effectiveness of Computed tomography-guided nasotracheal intubation in predicting tube advancement difficulty and preventing epistaxis.
Material and Methods: 60 maxillofacial surgery patients were included in the study. The space where the tube will be passed in the internal nasal valve region was measured horizontally (distance between inferior concha and septum) and vertically (distance between inferior concha and hard palate) by Computed Tomography. The patients were divided into two groups, 'easy' (n=28) or 'difficult' (n=32), according to the effort required to advance the tube through the nasal passage.
ROC analysis was performed, and cut-off values were determined to reveal the distance values at which difficulty may be experienced while advancing the tube. The cut-off values were 1.09 cm and 0.39 cm for the vertically and horizontally distances, respectively.
- Conditions
- Computed Tomography-guided Nasotracheal Intubation, The Space Where the Tube Will be Passed in the Internal Nasal Valve Region
- Being tested
- computed tomography-guided nasotracheal intubation
- Keywords
- Computed Tomography, epistaxis, Maxillofacial Orthognathic Surgery, Intubation
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography-guided nasotracheal intubationProcedure or surgery
Before intubation, the lower part of the nasal valve region, aka the narrowest area of the nasal passage, was measured by calculating the distance between the anterior border of the inferior concha and the septal cartilage
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the relationship between internal nasal valve measurements and nasal advancement of the intubation tube
The measurements were carried out from the coronal sections at 0.25 intervals. Before intubation, the lower part of the nasal valve region, aka the narrowest area of the nasal passage, was measured by calculating the distance between the anterior border of the inferior concha and the septal cartilage. Additionally, using the same section of the CT image, the distance between the inferior concha and the hard palate was measured
Measured: during intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2022
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 Computed Tomography-guided Nasotracheal IntubationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher orbay yasli, TC Erciyes University
- Investigators
- SEHER Orbay Yaşlı, Principal investigator, Erciyes University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525754
- Sponsor's protocol ID
- 2018 /No:377
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yasli SO, Canpolat DG, Baydan E, Demirbas AE. Effectiveness Of Computed Tomography-Guided Nasotracheal Intubation Procedure On Predicting Tube Advancement Difficulty And Preventing Epistaxis: A Prospective Case-Control Study. J Pak Med Assoc. 2023 Oct;73(10):1981-1986. doi: 10.47391/JPMA.8034.
PubMed 37876056
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Computed Tomography-Guided Nasotracheal Intubation Procedure on Predicting Tube Advancement Difficulty and Preventing Epistaxis: A Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT05525754
- Acronym / sponsor ID
- 2018 /No:377
- Conditions
- Computed Tomography-guided Nasotracheal Intubation, The Space Where the Tube Will be Passed in the Internal Nasal Valve Region
- Keywords
- Computed Tomography, epistaxis, Maxillofacial Orthognathic Surgery, Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 2 Sep 2022 (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.
Background: Nasotracheal intubation can lead to severe complications like epistaxis with excessive bleeding. The advancement difficulty of the tube faced during nasal intubation is one of the fundamental causes of this condition. The present study aimed to evaluate the effectiveness of Computed tomography-guided nasotracheal intubation in predicting tube advancement difficulty and preventing epistaxis.
Material and Methods: 60 maxillofacial surgery patients were included in the study. The space where the tube will be passed in the internal nasal valve region was measured horizontally (distance between inferior concha and septum) and vertically (distance between inferior concha and hard palate) by Computed Tomography. The patients were divided into two groups, 'easy' (n=28) or 'difficult' (n=32), according to the effort required to advance the tube through the nasal passage.
ROC analysis was performed, and cut-off values were determined to reveal the distance values at which difficulty may be experienced while advancing the tube. The cut-off values were 1.09 cm and 0.39 cm for the vertically and horizontally distances, respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty health volunteers who went orthognathic surgery
Key inclusion criteria (2 listed)
- Aged 18 to 65 who underwent bimaxillary orthognathic surgery
- defined as ASA (American Society of Anesthesiology) I or II
Key exclusion criteria (5 listed)
- The lack of preoperative CT scans
- airways evaluated and considered difficult by the anesthesiologist
- airways assessed and considered not appropriate for right angle endotracheal (RAE) tube with7.0 mm internal diameter
- history of sinusitis or head trauma
- anticoagulant therapy
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 |
|---|---|---|
| computed tomography-guided nasotracheal intubationBefore intubation, the lower part of the nasal valve region, aka the narrowest area of the nasal passage, was measured by calculating the distance between the anterior border of the inferior concha and the septal cartilage | Procedure or surgery | – |
Primary outcome
Investigation of the relationship between internal nasal valve measurements and nasal advancement of the intubation tube
Time frame: during intubation procedure
The measurements were carried out from the coronal sections at 0.25 intervals. Before intubation, the lower part of the nasal valve region, aka the narrowest area of the nasal passage, was measured by calculating the distance between the anterior border of the inferior concha and the septal cartilage. Additionally, using the same section of the CT image, the distance between the inferior concha and the hard palate was measured
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 2 Sep 2022.
- Derived from this study: PubMed 37876056Yasli SO, Canpolat DG, Baydan E, Demirbas AE. Effectiveness Of Computed Tomography-Guided Nasotracheal Intubation Procedure On Predicting Tube Advancement Difficulty And Preventing Epistaxis: A Prospective Case-Control Study. J Pak Med Assoc. 2023 Oct;73(10):1981-1986. doi: 10.47391/JPMA.8034.
- Individual participant dataSharing planned: No
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.
SEHER Orbay Yaşlı principal investigator
Erciyes University Faculty of Dentistry
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 Computed Tomography-guided Nasotracheal Intubation and The Space Where the Tube Will be Passed in the Internal Nasal Valve Region, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 2 Sep 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 Turkey (Türkiye). 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?
Investigation of the relationship between internal nasal valve measurements and nasal advancement of the intubation tube (time frame: during intubation procedure). 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 NCT05525754, 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 2 Sep 2022.