Nasotracheal IntubationNCT03086668
Fingers Hook Technique to Facilitate Nasotracheal Intubation
A study testing Conventional Jaw thrust Group and Fingers hook Group in people with Nasotracheal Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
to compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasotracheal Intubation
- What is being tested?
- Conventional Jaw thrust Group and Fingers hook Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Mar 2017to 5 Nov 2019
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with American Society of Anesthesiologists physical status I-III
- aged 20-65 years
- Requiring general anesthesia undergoing oxo-maxillofacial surgery
- unlimited mouth open
- unlimited neck motion
Who cannot join
- mouth open < 3 cm
- Ankylosing arthritis patients.
- BMI≧35 kg/m2
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, 807
About this study
Official title: Tube-Videostylet Assembly for Nasotracheal Intubation Assisted by a Fingers-Hook Technique
to compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation
Read the detailed description
It is necessary to adequately exposure of glottis during naso-tracheal intubation using video-stylet. However, inadequate upward epiglottis or over-elevation of arytenoids all inhibit the tube tip smoothly into trachea. Therefore, the study is to investigate either jaw thrust or fingers-hook technique is advantages of nasotracheal intubation.
- Conditions
- Nasotracheal Intubation
- Being tested
- Conventional Jaw thrust Group, Fingers hook Group
- Keywords
- Nasotracheal Intubation, jaw thrust, hook-finger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Jaw thrust GroupProcedure or surgery
a video-stylet assisted nasotracheal intubation and facilitate by conventional jaw thrust technique
Fingers hook GroupProcedure or surgery
a video-stylet assisted nasotracheal intubation and facilitate by fingers-hook technique
| Study group | Role | What they receive |
|---|---|---|
| Conventional Jaw thrust Group | Experimental | an assembly of video-stylet and double curve endotracheal tube with conventional jaw thrust technique to facilitate nasotracheal intubation Receives: Procedure: Conventional Jaw thrust Group |
| Fingers hook Group | Experimental | an assembly of video-stylet and double curve endotracheal tube with fingers-hook technique to facilitate nasotracheal intubation Receives: Procedure: Fingers hook Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade of glottic field exposure and nasotracheal difficulty intubation score
to compare the two different techniques in glottic field exposure and score of nasotracheal difficulty intubations scale
Measured: half an hour
Secondary outcomes (1)
the tube-videostylet assembly range of motion
range motion of tip of tube-videostylet assembly advanced from nasal cavity to trachea
Measured: half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start27 Mar 2017
- Primary completion11 Nov 2018
- Study completion5 Nov 2019
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 Nasotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang I Cheng, MD, PhD, Study director, Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086668
- Sponsor's protocol ID
- KMUHIRB-E(I)-20160019
- Status last verified
- Aug 2018
- First submitted
- 1 Feb 2017
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng KI, Yun MK, Chang MC, Lee KW, Huang SC, Tang CS, Chen CH. Fiberoptic bronchoscopic view change of laryngopharyngeal tissues by different airway supporting techniques: comparison of patients with and without open mouth limitation. J Clin Anesth. 2008 Dec;20(8):573-9. doi: 10.1016/j.jclinane.2008.01.013.
PubMed 19100929
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tube-Videostylet Assembly for Nasotracheal Intubation Assisted by a Fingers-Hook Technique
- ClinicalTrials.gov ID
- NCT03086668
- Acronym / sponsor ID
- KMUHIRB-E(I)-20160019
- Conditions
- Nasotracheal Intubation
- Keywords
- Nasotracheal Intubation, jaw thrust, hook-finger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 22 Mar 2017 (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 compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation
Detailed description
It is necessary to adequately exposure of glottis during naso-tracheal intubation using video-stylet. However, inadequate upward epiglottis or over-elevation of arytenoids all inhibit the tube tip smoothly into trachea. Therefore, the study is to investigate either jaw thrust or fingers-hook technique is advantages of nasotracheal intubation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Jaw thrust Group | Experimental | Procedure: Conventional Jaw thrust Groupan assembly of video-stylet and double curve endotracheal tube with conventional jaw thrust technique to facilitate nasotracheal intubation |
| Fingers hook Group | Experimental | Procedure: Fingers hook Groupan assembly of video-stylet and double curve endotracheal tube with fingers-hook technique to facilitate nasotracheal intubation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with American Society of Anesthesiologists physical status I-III
- aged 20-65 years
- Requiring general anesthesia undergoing oxo-maxillofacial surgery
- unlimited mouth open
- unlimited neck motion
Key exclusion criteria (3 listed)
- mouth open < 3 cm
- Ankylosing arthritis patients.
- BMI≧35 kg/m2
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 |
|---|---|---|
| Conventional Jaw thrust Groupa video-stylet assisted nasotracheal intubation and facilitate by conventional jaw thrust technique | Procedure or surgery | Conventional Jaw thrust Group |
| Fingers hook Groupa video-stylet assisted nasotracheal intubation and facilitate by fingers-hook technique | Procedure or surgery | Fingers hook Group |
Primary outcome
grade of glottic field exposure and nasotracheal difficulty intubation score
Time frame: half an hour
to compare the two different techniques in glottic field exposure and score of nasotracheal difficulty intubations scale
1 secondary outcome
the tube-videostylet assembly range of motion
Time frame: half an hour
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 21 Jun 2024.
- Background: PubMed 19100929Cheng KI, Yun MK, Chang MC, Lee KW, Huang SC, Tang CS, Chen CH. Fiberoptic bronchoscopic view change of laryngopharyngeal tissues by different airway supporting techniques: comparison of patients with and without open mouth limitation. J Clin Anesth. 2008 Dec;20(8):573-9. doi: 10.1016/j.jclinane.2008.01.013.
- Individual participant dataSharing planned: No
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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.
Kuang I Cheng, MD, PhD study director
Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University,Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Jaw thrust Group and Fingers hook Group in people with Nasotracheal Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 3 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 21 Jun 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 Taiwan. 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?
grade of glottic field exposure and nasotracheal difficulty intubation score (time frame: half an hour). 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 NCT03086668, 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 21 Jun 2024.