Intubation, Nasotracheal IntubationNCT02448277
Comparison of Different Tools Inserted Nasal Endotracheal Tube
A study testing Macintosh Laryngoscope, Pentax Airway scope and Glidescope in people with Intubation, Nasotracheal Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal intubation, limited information presents in NTI. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Nasotracheal Intubation
- What is being tested?
- Macintosh Laryngoscope, Pentax Airway scope and Glidescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Dec 2015
- 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
Who cannot join
- mouth open < 3 cm
- limited neck extension < 25 degree
- 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 City, Kaohsiung, 807
About this study
Official title: A Comparson Among the Use of Direct Laryngoscope.AirwayScope and GlideScope in General Anesthetized Patients Who Require Nasal Endotracheal Tube Intubation
Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal intubation, limited information presents in NTI. The aim of the study is to compare the efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.
- Conditions
- Intubation, Nasotracheal Intubation
- Being tested
- Macintosh Laryngoscope, Pentax Airway scope, Glidescope
- Keywords
- Macintosh laryngoscope, Pentax, Glidescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh LaryngoscopeDevice
Also called Macintoish laryngoscope
the device is to assist nasotracheal intubation
Pentax Airway scopeDevice
the device is to assist the nasotracheal tube into trachea
GlidescopeDevice
the device is to assist the nasotracheal tube into trachea
| Study group | Role | What they receive |
|---|---|---|
| Macintosh Laryngoscope | Experimental | experimental Macintosh Laryngoscope group: laryngoscope is used to assist for nasotracheal intubation. Receives: Device: Macintosh Laryngoscope |
| Pentax Airway scope | Experimental | experimental Pentax Airway scope group:Pentax Airway scope is used to assist for nasotracheal intubation. Receives: Device: Pentax Airway scope |
| Glidescope | Experimental | experimental Glidescope group:Glidescope is used to assist nasotracheal tube into trachea Receives: Device: Glidescope |
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 difficult intubation scale
Nasotracheal intubation assisted by a video-stylet may be performed in patients following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg, cis-atracurium 0.2 mg/kg and propofol 1 mg/kg)
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 termination of mask ventilation and mask removed 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: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang Yi Tseng, M.D., Study director, Department of anesthesiology, Kaohsiung Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448277
- Sponsor's protocol ID
- KMUH-IRB-990188
- Status last verified
- Apr 2011
- First submitted
- 15 May 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparson Among the Use of Direct Laryngoscope.AirwayScope and GlideScope in General Anesthetized Patients Who Require Nasal Endotracheal Tube Intubation
- ClinicalTrials.gov ID
- NCT02448277
- Acronym / sponsor ID
- KMUH-IRB-990188
- Conditions
- Intubation, Nasotracheal Intubation
- Keywords
- Macintosh laryngoscope, Pentax, Glidescope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 May 2015 (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.
Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal intubation, limited information presents in NTI. The aim of the study is to compare the efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macintosh Laryngoscope | Experimental | Device: Macintosh Laryngoscopeexperimental Macintosh Laryngoscope group: laryngoscope is used to assist for nasotracheal intubation. |
| Pentax Airway scope | Experimental | Device: Pentax Airway scopeexperimental Pentax Airway scope group:Pentax Airway scope is used to assist for nasotracheal intubation. |
| Glidescope | Experimental | Device: Glidescopeexperimental Glidescope group:Glidescope is used to assist nasotracheal tube into trachea |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with American Society of Anesthesiologists physical status I-III
- aged 20-65 years
- Requiring Nasotracheal Intubation under general anesthesia
Key exclusion criteria (4 listed)
- mouth open < 3 cm
- limited neck extension < 25 degree
- 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 |
|---|---|---|
| Macintosh LaryngoscopeAlso: Macintoish laryngoscopethe device is to assist nasotracheal intubation | Device | Macintosh Laryngoscope |
| Pentax Airway scopethe device is to assist the nasotracheal tube into trachea | Device | Pentax Airway scope |
| Glidescopethe device is to assist the nasotracheal tube into trachea | Device | Glidescope |
Primary outcome
number of the patients with successful nasotracheal intubation and scoring difficult intubation scale
Time frame: half an hour
Nasotracheal intubation assisted by a video-stylet may be performed in patients following induction of anesthesia (fentanyl 2 micro-gram/kg, thiamylal 5 mg/kg, cis-atracurium 0.2 mg/kg and propofol 1 mg/kg)
1 secondary outcome
time to intubate
Time frame: 10 minutes
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 22 Mar 2017.
Related trials for Intubation, Nasotracheal Intubation
Not yet recruiting
ASIGN Trial- Angulated Versus Standard Video-laryngoscope Blade in Nasal Intubation
Nasal Intubation
Recruiting
Comparison of Awake Tracheal Intubation Methods
Airway Management Assessment, Awake Endotracheal Intubation
Recruiting
Fibrescope vs Videolaryngoscope for Nasotracheal Intubation
No Disease
Recruiting
Nostril Side on Epistaxis
Nasotracheal Intubation
Recruiting
The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy
Hypoxia, Pulmonary Nodule
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 Yi Tseng, M.D. study director
Department of anesthesiology, 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 Macintosh Laryngoscope, Pentax Airway scope and Glidescope in people with Intubation, 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 3 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 22 Mar 2017. 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?
number of the patients with successful nasotracheal intubation and scoring difficult intubation 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 22 Mar 2017.