Intubation; Difficult or FailedNCT06247969
Cone Beam Computed Tomography For Appropriate Nostril Selection for Nasotracheal Intubation
An observational study of Intubation; Difficult or Failed and Intubation Complication, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Design: Nasotracheal intubation is a standard blind procedure associated with various complications. Selection of the appropriate nostril is crucial in preventing most of these complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication
- What is being tested?
- endotracheal tube
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2023to 5 Feb 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population in this study consists ASA I-II patients, aged 18-70 years old, who had undergone maxillofacial surgery under general anesthesia with nasotracheal intubation and had undergone CBCT examination of maxillofacial area for various reasons before the operation.
Who may be able to join
- ASA I-II patients
Who cannot join
- Clinical diagnosis of allergic rhinitis
- Patient with structural abnormalities in maxillo-mandibular anatomy,
- Patient with limited mouth opening
- Patient has previous history of epistaxis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Dentistry
Konya, 42130
About this study
Official title: Using Cone Beam Computed Tomography For Appropriate Nostril Selection In Nasotracheal Intubation
Design: Nasotracheal intubation is a standard blind procedure associated with various complications. Selection of the appropriate nostril is crucial in preventing most of these complications. The investigators aimed to evaluate the contribution of CBCT findings in selecting the proper nostril for nasotracheal intubation.
Methods: This prospective observational study outlines the protocol for research conducted at the Selçuk University Faculty of Dentistry.
Read more
Scope of the Research: The study encompasses patients undergoing dental surgery under general anesthesia at the Selçuk University Faculty of Dentistry.
- Participant Selection: ASA I-II patients will be included in the study. Patients with structural abnormalities in the maxillo-mandibular anatomy, limited mouth opening, comorbidities such as rheumatoid arthritis, and a history of epistaxis will be excluded from the study.
- Anesthesia Method: General anesthesia induction will be performed with intravenous (IV) propofol, IV rocuronium bromide, and IV fentanyl. Transition to nasotracheal intubation will follow adequate mask ventilation, and the preferred nostril will be determined through a simple occlusion test.
- Data Collection: Demographic data, accompanying illnesses, medications used, and various parameters related to nasotracheal intubation will be recorded. The anesthetist performing nasotracheal intubation will be blinded to CBCT data, and the evaluation of data will be conducted jointly by the anesthetist and Radiology specialist after data collection from all patients is complete.
- Exclusion Criteria: Unsuccessful nasotracheal intubation, difficult mask, and/or difficult intubation.
- Implementation and Evaluation: Anesthesia procedures and CBCT evaluations will be carried out by experienced specialists.
- The objective of this study is to evaluate the use of preoperative measurements of the nasal cavity from CBCT images in selecting the appropriate nostril for nasotracheal intubation under general anesthesia. The statistical tests to be employed are the chi-squared test and independent samples t-test.
Read the detailed description
The goal of this prospective observational study is the contribution of CBCT findings in selecting the proper nostril for nasotracheal intubation. The main question it aim to answer is:
- Can pre-operative evaluations of participiants' nasal cavity by using CBCT aid anesthetists for selecting the appropriate nostril for nasotracheal intubation? The participants will be informed both through a written consent form, and verbally that they would be participating in the observational study, and that apart from routine procedures, no additional interventions would be performed.
- Being tested
- endotracheal tube
- Keywords
- cone-beam computed tomography, intubation, nasal cavity, nasal septum, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tubeDevice
Endotracheal Tube (ETT) is a flexible plastic tube that is inserted through the mouth or nose into the trachea to establish an artificial airway.
| Study group | Role | What they receive |
|---|---|---|
| Patients intubated under general anesthesia via nasotracheal route. | Patients intubated under general anesthesia via nasotracheal route successfully. Receives: Device: endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the use of preoperative measurements of the nasal cavity from CBCT images in selecting the appropriate nostril for nasotracheal intubation under general anesthesia.
The proper selection of the nostril is crucial in preventing complications such as bleeding associated with nasotracheal intubation. In this regard, we investigated the potential utility of Cone Beam Computed Tomography (CBCT), a commonly available imaging method in dental hospitals, as an assisting tool for anesthetists.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Dec 2023
- Primary completion1 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FUNDA ARUN, Selcuk University
- Investigators
- FUNDA ARUN, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247969
- Sponsor's protocol ID
- F001
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cone Beam Computed Tomography For Appropriate Nostril Selection In Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT06247969
- Acronym / sponsor ID
- F001
- Keywords
- cone-beam computed tomography, intubation, nasal cavity, nasal septum, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 8 Feb 2024 (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.
Design: Nasotracheal intubation is a standard blind procedure associated with various complications. Selection of the appropriate nostril is crucial in preventing most of these complications. The investigators aimed to evaluate the contribution of CBCT findings in selecting the proper nostril for nasotracheal intubation.
Methods: This prospective observational study outlines the protocol for research conducted at the Selçuk University Faculty of Dentistry.
Scope of the Research: The study encompasses patients undergoing dental surgery under general anesthesia at the Selçuk University Faculty of Dentistry.
- Participant Selection: ASA I-II patients will be included in the study. Patients with structural abnormalities in the maxillo-mandibular anatomy, limited mouth opening, comorbidities such as rheumatoid arthritis, and a history of epistaxis will be excluded from the study.
- Anesthesia Method: General anesthesia induction will be performed with intravenous (IV) propofol, IV rocuronium bromide, and IV fentanyl. Transition to nasotracheal intubation will follow adequate mask ventilation, and the preferred nostril will be determined through a simple occlusion test.
- Data Collection: Demographic data, accompanying illnesses, medications used, and various parameters related to nasotracheal intubation will be recorded. The anesthetist performing nasotracheal intubation will be blinded to CBCT data, and the evaluation of data will be conducted jointly by the anesthetist and Radiology specialist after data collection from all patients is complete.
- Exclusion Criteria: Unsuccessful nasotracheal intubation, difficult mask, and/or difficult intubation.
- Implementation and Evaluation: Anesthesia procedures and CBCT evaluations will be carried out by experienced specialists.
- The objective of this study is to evaluate the use of preoperative measurements of the nasal cavity from CBCT images in selecting the appropriate nostril for nasotracheal intubation under general anesthesia. The statistical tests to be employed are the chi-squared test and independent samples t-test.
Detailed description
The goal of this prospective observational study is the contribution of CBCT findings in selecting the proper nostril for nasotracheal intubation. The main question it aim to answer is:
- Can pre-operative evaluations of participiants' nasal cavity by using CBCT aid anesthetists for selecting the appropriate nostril for nasotracheal intubation? The participants will be informed both through a written consent form, and verbally that they would be participating in the observational study, and that apart from routine procedures, no additional interventions would be performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients intubated under general anesthesia via nasotracheal route. | – | Device: endotracheal tubePatients intubated under general anesthesia via nasotracheal route successfully. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population in this study consists ASA I-II patients, aged 18-70 years old, who had undergone maxillofacial surgery under general anesthesia with nasotracheal intubation and had undergone CBCT examination of maxillofacial area for various reasons before the operation.
Key inclusion criteria (1 listed)
- ASA I-II patients
Key exclusion criteria (4 listed)
- Clinical diagnosis of allergic rhinitis
- Patient with structural abnormalities in maxillo-mandibular anatomy,
- Patient with limited mouth opening
- Patient has previous history of epistaxis
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 |
|---|---|---|
| endotracheal tubeEndotracheal Tube (ETT) is a flexible plastic tube that is inserted through the mouth or nose into the trachea to establish an artificial airway. | Device | Patients intubated under general anesthesia via nasotracheal route. |
Primary outcome
Evaluation the use of preoperative measurements of the nasal cavity from CBCT images in selecting the appropriate nostril for nasotracheal intubation under general anesthesia.
Time frame: 4 weeks
The proper selection of the nostril is crucial in preventing complications such as bleeding associated with nasotracheal intubation. In this regard, we investigated the potential utility of Cone Beam Computed Tomography (CBCT), a commonly available imaging method in dental hospitals, as an assisting tool for anesthetists.
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 18 Apr 2024.
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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.
FUNDA ARUN principal investigator
Selcuk University
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 Intubation; Difficult or Failed and Intubation Complication, run by Selcuk 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 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 18 Apr 2024. 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?
Evaluation the use of preoperative measurements of the nasal cavity from CBCT images in selecting the appropriate nostril for nasotracheal intubation under general anesthesia. (time frame: 4 weeks). 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 18 Apr 2024.