Nasotracheal IntubationNCT04164836
Effect of Nose Selection Using Rhnoscope on Epistaxis of Nasotracheal Intubation
A study testing rhinoscope in people with Nasotracheal Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Rhinoscope is useful to exam intranasal structure. This information could be utilized to select more suitable nose for nasotracheal intubation. Nastoracheal intubation using more patent nose could be associated with decrease of the development of epistaxis which is most common complication in nasotracheal intubation. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Nasotracheal Intubation
- What is being tested?
- rhinoscope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Nov 2019to 30 Mar 2022
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II undergoing surgery under nasotracheal intubation
Who cannot join
- expected difficult intubation based on history, physical examination, weight.
- bleeding tendency
- past history of nasal surgery
- symptom of difficulty of nasal respiration
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou universitiy school of medicine
Suwon, Gyeong-gi Do, 16499
About this study
Official title: The Effect of Suitable Nose Selection Using Rhinoscope on the Incidence and Severity of Epistaxis After Nasotracheal Intubation.
Rhinoscope is useful to exam intranasal structure. This information could be utilized to select more suitable nose for nasotracheal intubation. Nastoracheal intubation using more patent nose could be associated with decrease of the development of epistaxis which is most common complication in nasotracheal intubation.
Read the detailed description
Anterior rhinoscopy using rhinoscope is a simple way to view the intranasal structure, which allows you to observe the nasal mucosa, the inferior nasal concha, and in some cases, the nasal concha. You can see the nasal septum, polyps, and intranasal malformations. In addition, even when there are no structural abnormalities in the nasal cavity, the wider nasal cavity can be intuitively identified. This information is expected to assist in the selection of nostrils. It has not yet been studied whether anesthesiologists select nasal cavity for nasotracheal intubation using prosthesis can affect the occurrence of epistaxis.
The purpose of this study is to determine whether the selection of a nostril for nasotracheal intubation by rhinoscope affects the incidence and severity of epistaxis.
- Conditions
- Nasotracheal Intubation
- Being tested
- rhinoscope
- Keywords
- epistaxis, rhinoscope
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhinoscopeDiagnostic test
more suitable nose for nasotracheal intubation will be selected based on the view of rhinoscope.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | nose selection will be done by random table |
| rhinoscope group | Experimental | nose selection will be done by rhinoscopy Receives: Diagnostic Test: rhinoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of epistaxis
percentage of the development of epistaxis after nasotracheal intubation
Measured: immediate after intubation
incidence of epistaxis
percentage of the development of epistaxis after nasotracheal intubation
Measured: 5 min after intubation
Secondary outcomes (2)
severity of epistaxis4. severe: interfere intubation by blood
score based on severity of epistaxis will be recorded.
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx
Measured: immediate after intubation
severity of epistaxis
score based on severity of epistaxis will be recorded.
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx
Measured: 5 min after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start26 Nov 2019
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
- Investigators
- yun jeong chae, PhD MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164836
- Sponsor's protocol ID
- AJIRB-MED-OBS-19-201
- Status last verified
- Jul 2022
- First submitted
- 12 Nov 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share data when reasonable personal request exist.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suitable Nose Selection Using Rhinoscope on the Incidence and Severity of Epistaxis After Nasotracheal Intubation.
- ClinicalTrials.gov ID
- NCT04164836
- Acronym / sponsor ID
- AJIRB-MED-OBS-19-201
- Conditions
- Nasotracheal Intubation
- Keywords
- epistaxis, rhinoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 15 Nov 2019 (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.
Rhinoscope is useful to exam intranasal structure. This information could be utilized to select more suitable nose for nasotracheal intubation. Nastoracheal intubation using more patent nose could be associated with decrease of the development of epistaxis which is most common complication in nasotracheal intubation.
Detailed description
Anterior rhinoscopy using rhinoscope is a simple way to view the intranasal structure, which allows you to observe the nasal mucosa, the inferior nasal concha, and in some cases, the nasal concha. You can see the nasal septum, polyps, and intranasal malformations. In addition, even when there are no structural abnormalities in the nasal cavity, the wider nasal cavity can be intuitively identified. This information is expected to assist in the selection of nostrils. It has not yet been studied whether anesthesiologists select nasal cavity for nasotracheal intubation using prosthesis can affect the occurrence of epistaxis.
The purpose of this study is to determine whether the selection of a nostril for nasotracheal intubation by rhinoscope affects the incidence and severity of epistaxis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –nose selection will be done by random table |
| rhinoscope group | Experimental | Diagnostic Test: rhinoscopenose selection will be done by rhinoscopy |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I or II undergoing surgery under nasotracheal intubation
Key exclusion criteria (4 listed)
- expected difficult intubation based on history, physical examination, weight.
- bleeding tendency
- past history of nasal surgery
- symptom of difficulty of nasal respiration
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 |
|---|---|---|
| rhinoscopemore suitable nose for nasotracheal intubation will be selected based on the view of rhinoscope. | Diagnostic test | rhinoscope group |
Primary outcome
incidence of epistaxis
Time frame: immediate after intubation
percentage of the development of epistaxis after nasotracheal intubation
incidence of epistaxis
Time frame: 5 min after intubation
percentage of the development of epistaxis after nasotracheal intubation
2 secondary outcomes
severity of epistaxis4. severe: interfere intubation by blood
Time frame: immediate after intubation
severity of epistaxis
Time frame: 5 min after intubation
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 26 Jul 2022.
- Individual participant dataSharing planned: No. We will share data when reasonable personal request exist.
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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.
yun jeong chae, PhD MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhinoscope in people with Nasotracheal Intubation, run by Ajou University School of Medicine 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 26 Jul 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 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?
incidence of epistaxis (time frame: immediate after intubation). The study lists 2 primary outcomes in all. 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 26 Jul 2022.