Intubation;DifficultNCT04459481
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
A study testing bending angle in people with Intubation;Difficult, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown. In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- bending angle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2020to 5 Nov 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients require nasotracheal intubation
Who cannot join
- fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status
Trial locations and contacts
1 site in 1 country.
About this study
Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown. In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different bending angles.
Read the detailed description
intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded and compared.
- Conditions
- Intubation;Difficult
- Being tested
- bending angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bending angleDevice
patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle
| Study group | Role | What they receive |
|---|---|---|
| 70-degree bending angle group | Experimental | intubation with a 70-degree bending angle Receives: Device: bending angle |
| 90-degree bending angle group | Experimental | intubation with a 90-degree bending angle Receives: Device: bending angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of nasotracheal intubation
The percentage of successful nasotracheal intubation
Measured: Procedure (From the beginning of intubation to the end of intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start4 Jun 2020
- Primary completion3 Nov 2020
- Study completion5 Nov 2020
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 Intubation;DifficultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhui Liu, Chinese Academy of Medical Sciences
- Investigators
- Xiaoming Deng, MD, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459481
- Sponsor's protocol ID
- PSH-2018-13
- Status last verified
- Jan 2021
- First submitted
- 2 Jul 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Liu J, Xu W, Jin Z, Deng X. Does Increasing the Bend Angle of a Stylet to 90 degrees Increase the Nasotracheal Intubation Success Rate? J Oral Maxillofac Surg. 2024 Feb;82(2):152-158. doi: 10.1016/j.joms.2023.10.005. Epub 2023 Oct 19.
PubMed 37926429
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
- ClinicalTrials.gov ID
- NCT04459481
- Acronym / sponsor ID
- PSH-2018-13
- Conditions
- Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 7 Jul 2020 (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.
Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown. In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different bending angles.
Detailed description
intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 70-degree bending angle group | Experimental | Device: bending angleintubation with a 70-degree bending angle |
| 90-degree bending angle group | Experimental | Device: bending angleintubation with a 90-degree bending angle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients require nasotracheal intubation
Key exclusion criteria (1 listed)
- fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status
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 |
|---|---|---|
| bending anglepatients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle | Device | 70-degree bending angle group, 90-degree bending angle group |
Primary outcome
Success rate of nasotracheal intubation
Time frame: Procedure (From the beginning of intubation to the end of intubation)
The percentage of successful nasotracheal 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 15 Jan 2021.
- Derived from this study: PubMed 37926429Liu J, Xu W, Jin Z, Deng X. Does Increasing the Bend Angle of a Stylet to 90 degrees Increase the Nasotracheal Intubation Success Rate? J Oral Maxillofac Surg. 2024 Feb;82(2):152-158. doi: 10.1016/j.joms.2023.10.005. Epub 2023 Oct 19.
- Individual participant dataSharing planned: Yes
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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.
Xiaoming Deng, MD principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bending angle in people with Intubation;Difficult, run by Chinese Academy of Medical Sciences 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 1 inclusion and 1 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 15 Jan 2021. 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. 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?
Success rate of nasotracheal intubation (time frame: Procedure (From the beginning of intubation to the end of 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 NCT04459481, 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 15 Jan 2021.