IntubationNCT05218590
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?
A study testing Video rigid stylet in people with Intubation and Video Rigid Stylet, run by Peking University at 1 site in China.
Trial summary
To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation, Video Rigid Stylet
- What is being tested?
- Video rigid stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2022to 16 Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- American Society of Anesthesiologists physical status I~II;
- Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
- The expected operation time < 3 hours;
- Extubation in operation room and do not scheduled to preventive tracheotomy;
- Patients who were able to breathe clearly and equally through both nostrils.
Who cannot join
- Patients had history of difficult intubation or presented with an anticipated difficult airway;
- Patients requiring nasogastric tube insertion;
- Presence of contraindications of nasal intubation;
- Due to surgical requirement, intubation must be completed through one nostril;
- Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
- History of severe epistaxis or epistaxis within a month;
Show all 11Show fewer
- Previous history of nasal and/or laryngeal surgery;
- Previous experience with nasal intubation;
- History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
- Participate in other clinical studies;
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better? A Randomized Clinical Trial
To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.
Read the detailed description
Head and neck surgeries usually require nasal intubation, which allows leeway for operative maneuvering in the mouth, pharynx, larynx, and neck. Previous studies have found that the right nostril is more appropriate for nasal intubation using direct laryngoscope or videolaryngoscope. It has been shown that the optical rigid stylet was also an appropriate tool for nasal intubation. However, nasal intubation with rigid optical stylet is technically different from that with laryngoscope. It is unknown whether the choice of nostril could affect the intubation using rigid optical stylet. The main aim is to determine which nostril is more suitable for nasal intubation with video rigid stylet.
- Conditions
- Intubation, Video Rigid Stylet
- Being tested
- Video rigid stylet
- Keywords
- Nasotracheal intubation, Nostril, Video rigid laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video rigid styletDevice
Nasal intubation was performed using the video rigid stylet.
| Study group | Role | What they receive |
|---|---|---|
| Right nostril group | Active comparator | Nasal intubation with video rigid stylet was performed through the right nostril. Receives: Device: Video rigid stylet |
| Left nostril group | Placebo comparator | Nasal intubation with video rigid stylet was performed through the left nostril. Receives: Device: Video rigid stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time for intubation
The duration from when the device tip entered the nostril to when the tube entered the trachea, as confirmed by capnography.
Measured: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
Secondary outcomes (6)
Total success rate
Total success rate of nasal intubation with video rigid stylet.
Measured: Procedure (Up to the tube entered the trachea.)
First-attempt success
First-attempt success of nasal intubation with video rigid stylet.
Measured: First-attempt of nasal intubation with video rigid stylet.
Times of intubation-attempts
Times of intubation-attempts.
Measured: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
The time for device insertion
The duration from when the device tip entered the nostril to when it passed through the vocal cord.
Measured: Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.)
The time for tube insertion
The duration from when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.
Measured: Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.)
Incidence and severity of epistaxis
Incidence and severity of epistaxis
Measured: Procedure (Up to completion of intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start8 Feb 2022
- Primary completion15 Apr 2022
- Study completion16 Apr 2022
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 IntubationStudies of the same condition, open and under way.
- More trials run by Peking 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Hospital of Stomatology
- Responsible party
- Principal investigator, Yang Xudong, Peking University
- Investigators
- Xudong Yang, MD, PhD, Study director, Peking University School and Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218590
- Sponsor's protocol ID
- 20220108
- Status last verified
- Apr 2022
- First submitted
- 30 Jan 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tan YL, Wu ZH, Zhao BJ, Ni YH, Dong YC. For nasotracheal intubation, which nostril results in less epistaxis: right or left?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Nov 1;38(11):1180-1186. doi: 10.1097/EJA.0000000000001462.
PubMed 34617919Boku A, Hanamoto H, Hirose Y, Kudo C, Morimoto Y, Sugimura M, Niwa H. Which nostril should be used for nasotracheal intubation: the right or left? A randomized clinical trial. J Clin Anesth. 2014 Aug;26(5):390-4. doi: 10.1016/j.jclinane.2014.01.016. Epub 2014 Aug 10.
PubMed 25113425Cheng T, Wang LK, Wu HY, Yang XD, Zhang X, Jiao L. Shikani Optical Stylet for Awake Nasal Intubation in Patients Undergoing Head and Neck Surgery. Laryngoscope. 2021 Feb;131(2):319-325. doi: 10.1002/lary.28763. Epub 2020 Jun 10.
PubMed 32521054Wang LK, Zhang X, Wu HY, Cheng T, Xiong GL, Yang XD. Impact of choice of nostril on nasotracheal intubation when using video rigid stylet: a randomized clinical trial. BMC Anesthesiol. 2022 Nov 24;22(1):360. doi: 10.1186/s12871-022-01910-3.
PubMed 36424554
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05218590
- Acronym / sponsor ID
- 20220108
- Conditions
- Intubation, Video Rigid Stylet
- Keywords
- Nasotracheal intubation, Nostril, Video rigid laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University Hospital of Stomatology
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 1 Feb 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.
To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.
Detailed description
Head and neck surgeries usually require nasal intubation, which allows leeway for operative maneuvering in the mouth, pharynx, larynx, and neck. Previous studies have found that the right nostril is more appropriate for nasal intubation using direct laryngoscope or videolaryngoscope. It has been shown that the optical rigid stylet was also an appropriate tool for nasal intubation. However, nasal intubation with rigid optical stylet is technically different from that with laryngoscope. It is unknown whether the choice of nostril could affect the intubation using rigid optical stylet. The main aim is to determine which nostril is more suitable for nasal intubation with video rigid stylet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right nostril group | Active comparator | Device: Video rigid styletNasal intubation with video rigid stylet was performed through the right nostril. |
| Left nostril group | Placebo comparator | Device: Video rigid styletNasal intubation with video rigid stylet was performed through the left nostril. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- American Society of Anesthesiologists physical status I~II;
- Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
- The expected operation time < 3 hours;
- Extubation in operation room and do not scheduled to preventive tracheotomy;
Key exclusion criteria (11 listed)
- Patients had history of difficult intubation or presented with an anticipated difficult airway;
- Patients requiring nasogastric tube insertion;
- Presence of contraindications of nasal intubation;
- Due to surgical requirement, intubation must be completed through one nostril;
- Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
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 |
|---|---|---|
| Video rigid styletNasal intubation was performed using the video rigid stylet. | Device | Left nostril group, Right nostril group |
Primary outcome
Total time for intubation
Time frame: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
The duration from when the device tip entered the nostril to when the tube entered the trachea, as confirmed by capnography.
6 secondary outcomes
Total success rate
Time frame: Procedure (Up to the tube entered the trachea.)
First-attempt success
Time frame: First-attempt of nasal intubation with video rigid stylet.
Times of intubation-attempts
Time frame: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
The time for device insertion
Time frame: Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.)
The time for tube insertion
Time frame: Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.)
Incidence and severity of epistaxis
Time frame: Procedure (Up to completion of 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 29 Apr 2022.
- Background: PubMed 34617919Tan YL, Wu ZH, Zhao BJ, Ni YH, Dong YC. For nasotracheal intubation, which nostril results in less epistaxis: right or left?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Nov 1;38(11):1180-1186. doi: 10.1097/EJA.0000000000001462.
- Background: PubMed 25113425Boku A, Hanamoto H, Hirose Y, Kudo C, Morimoto Y, Sugimura M, Niwa H. Which nostril should be used for nasotracheal intubation: the right or left? A randomized clinical trial. J Clin Anesth. 2014 Aug;26(5):390-4. doi: 10.1016/j.jclinane.2014.01.016. Epub 2014 Aug 10.
- Background: PubMed 32521054Cheng T, Wang LK, Wu HY, Yang XD, Zhang X, Jiao L. Shikani Optical Stylet for Awake Nasal Intubation in Patients Undergoing Head and Neck Surgery. Laryngoscope. 2021 Feb;131(2):319-325. doi: 10.1002/lary.28763. Epub 2020 Jun 10.
- Derived from this study: PubMed 36424554Wang LK, Zhang X, Wu HY, Cheng T, Xiong GL, Yang XD. Impact of choice of nostril on nasotracheal intubation when using video rigid stylet: a randomized clinical trial. BMC Anesthesiol. 2022 Nov 24;22(1):360. doi: 10.1186/s12871-022-01910-3.
Related trials for Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
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.
Xudong Yang, MD, PhD study director
Peking University School and Hospital of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video rigid stylet in people with Intubation and Video Rigid Stylet, run by Peking University at 1 site in China.
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 6 inclusion and 11 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 29 Apr 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 China. 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. Some participants in this study may receive a placebo. 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?
Total time for intubation (time frame: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)). 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 NCT05218590, 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 29 Apr 2022.