Anesthesia Intubation ComplicationNCT01917435
Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient
A study testing video-stylet and fiberoptic bronchoscope in people with Anesthesia Intubation Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth opening patients. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- video-stylet and fiberoptic bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Jun 2014
- 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 Nasotracheal Intubation under general anesthesia
- limited mouth open ,mouth open < 3 cm
- unlimited neck motion
Who cannot join
- Ankylosing arthritis patients.
- BMI≧35 kg/m2
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
Kuang I Cheng, MD, PhD, 073121101 ext. 7033, kuaich@kmu.edu.tw
About this study
Official title: Nasotracheal Intubation Assisted by a Video-stylet in Limited Mouth Opening Patient
The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth opening patients.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- video-stylet, fiberoptic bronchoscope
- Keywords
- fiberoptic bronchoscopy,, Video-stylet,, Nasotracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-styletDevice
Also called Device: video-stylet, Other Names:, The Clarus Video System
fiberoptic bronchoscopeDevice
Also called fiberscope
| Study group | Role | What they receive |
|---|---|---|
| fiberoptic bronchoscope | Experimental | Experimental: fiberoptic bronchoscope fiberoptic bronchoscope is used to facilitate for nasotracheal intubation. Receives: Device: fiberoptic bronchoscope |
| video-stylet | Experimental | Experimental: video-stylet video-stylet is used to facilitate for nasotracheal intubation. Receives: Device: video-stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of the patients with successful nasotracheal intubation and scoring modified intubation difficulty scale
Nasotracheal intubation is assisted by a video-stylet may be performed in patients undergoing Limited Mouth Opening following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg) and is facilitated by cis-atracurium 0.2 mg/kg administration. propofol 1 mg/kg intravenously to blunt hemodynamic responses while intubation.
a modified intubation difficulty scale to evaluate the difficulty of fiber-scope guided or trachway assisted nasotracheal intubation
Measured: half an hour
Secondary outcomes (1)
time to intubate
time of Intubating the nasotracheal tube (NT) from selected nostril to trachea is continuously calculated but separately into two parts. part one: from leaving off mask ventilation (mask removal from face), to the NT tip on the nasopharynx. part two: advancing NT from nasopharynx, through vocal cord into trachea, to present of 3 end tidal carbon dioxide waveforms.
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 posted6 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917435
- Sponsor's protocol ID
- KMUH-IRB-20120254
- Status last verified
- Aug 2013
- First submitted
- 10 Jul 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasotracheal Intubation Assisted by a Video-stylet in Limited Mouth Opening Patient
- ClinicalTrials.gov ID
- NCT01917435
- Acronym / sponsor ID
- KMUH-IRB-20120254
- Conditions
- Anesthesia Intubation Complication
- Keywords
- fiberoptic bronchoscopy,, Video-stylet,, Nasotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- 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.
The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth opening patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiberoptic bronchoscope | Experimental | Device: fiberoptic bronchoscopeExperimental: fiberoptic bronchoscope fiberoptic bronchoscope is used to facilitate for nasotracheal intubation. |
| video-stylet | Experimental | Device: video-styletExperimental: video-stylet video-stylet is used to facilitate for 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 Nasotracheal Intubation under general anesthesia
- limited mouth open ,mouth open < 3 cm
- unlimited neck motion
Key exclusion criteria (2 listed)
- 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 |
|---|---|---|
| video-styletAlso: Device: video-stylet, Other Names:, The Clarus Video System | Device | video-stylet |
| fiberoptic bronchoscopeAlso: fiberscope | Device | fiberoptic bronchoscope |
Primary outcome
number of the patients with successful nasotracheal intubation and scoring modified intubation difficulty scale
Time frame: half an hour
Nasotracheal intubation is assisted by a video-stylet may be performed in patients undergoing Limited Mouth Opening following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg) and is facilitated by cis-atracurium 0.2 mg/kg administration. propofol 1 mg/kg intravenously to blunt hemodynamic responses while intubation. a modified intubation difficulty scale to evaluate the difficulty of fiber-scope guided or trachway assisted nasotracheal intubation
1 secondary outcome
time to intubate
Time frame: half an hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
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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.
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-stylet and fiberoptic bronchoscope in people with Anesthesia Intubation Complication, 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 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuang I Cheng, MD, PhD (073121101 ext. 7033, kuaich@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of the patients with successful nasotracheal intubation and scoring modified intubation difficulty scale (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?
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 6 Aug 2013.