Nasotracheal IntubationNCT03086798
Comparison of Different Tools to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use
A study testing Magill forceps and cuff inflation in people with Nasotracheal Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
to investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea 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?
- Magill forceps and cuff inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Mar 2017to 30 Sep 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 Nasotracheal Intubation under general anesthesia
- 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 City, 807
About this study
Official title: Comparison Techniques of Magill Forceps and Cuff Inflation to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use
to investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea
Read the detailed description
Patients who undergo oxo-maxillofacial surgery need naso-tracheal intubation to present good surgical view-field. but, sometimes, the naso-tracheal tube is unable to advance from nasopharynx, oropharynx, into trachea without assistance. Using techniques of either Magill forceps or cuff inflation is advantageous is not determined.
- Conditions
- Nasotracheal Intubation
- Being tested
- Magill forceps, cuff inflation
- Keywords
- Magill forceps, cuff inflation, Nasotracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magill forcepsProcedure or surgery
Magill forceps techniques to facilitate nasotracheal tube advancement into trachea
cuff inflationProcedure or surgery
cuff inflation techniques to facilitate nasotracheal tube advancement into trachea
| Study group | Role | What they receive |
|---|---|---|
| Magill forceps | Experimental | experimental Magill forceps group: Magill forceps technique to facilitate nasotracheal tube advancement into trachea Receives: Procedure: Magill forceps |
| cuff inflation | Experimental | experimental cuff inflation group: cuff inflation technique to facilitate nasotracheal tube advancement into trachea Receives: Procedure: cuff inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the technique spending time in this time interval and first attempt successful rate
to measure the time taken of either using Magill forceps or with cuff inflation techniques in successfully intubated patients
Measured: 10 minutes
Secondary outcomes (3)
total intubation time taken
measure the whole intubation time taken from tube tip into selected nostril, to nasopharynx, to oropharynx, into trachea, till capnography showing of 3 consecutive CO2 waveforms
Measured: half an hour
glottic injury and cuff damages during tube advanced
to assess the bleeding point of glottic area and the cuff injury of endotracheal tube
Measured: half an hour
postoperative nasal bleeding, sore throat and hoarseness
Events of intubating related nasal bleeding were measured on selected nostril and oral cavity at 3 minutes post-intubation. Incidences of sore throat and hoarseness are evaluated before patients out of recovery room and the coming morning
Measured: 2 days
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 start31 Mar 2017
- Primary completion31 Aug 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 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, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086798
- Sponsor's protocol ID
- KMUHIRB-F(II)-20150058
- Status last verified
- Mar 2018
- First submitted
- 1 Feb 2017
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Techniques of Magill Forceps and Cuff Inflation to Facilitate Nasotracheal Tube Placement Under Video-laryngoscope Use
- ClinicalTrials.gov ID
- NCT03086798
- Acronym / sponsor ID
- KMUHIRB-F(II)-20150058
- Conditions
- Nasotracheal Intubation
- Keywords
- Magill forceps, cuff inflation, Nasotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Sep 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 investigate the effectiveness of techniques of either using Magill forceps or cuff inflation in facilitation of nasotracheal tube advancement into trachea
Detailed description
Patients who undergo oxo-maxillofacial surgery need naso-tracheal intubation to present good surgical view-field. but, sometimes, the naso-tracheal tube is unable to advance from nasopharynx, oropharynx, into trachea without assistance. Using techniques of either Magill forceps or cuff inflation is advantageous is not determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magill forceps | Experimental | Procedure: Magill forcepsexperimental Magill forceps group: Magill forceps technique to facilitate nasotracheal tube advancement into trachea |
| cuff inflation | Experimental | Procedure: cuff inflationexperimental cuff inflation group: cuff inflation technique to facilitate nasotracheal tube advancement into trachea |
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
- 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 |
|---|---|---|
| Magill forcepsMagill forceps techniques to facilitate nasotracheal tube advancement into trachea | Procedure or surgery | Magill forceps |
| cuff inflationcuff inflation techniques to facilitate nasotracheal tube advancement into trachea | Procedure or surgery | cuff inflation |
Primary outcome
the technique spending time in this time interval and first attempt successful rate
Time frame: 10 minutes
to measure the time taken of either using Magill forceps or with cuff inflation techniques in successfully intubated patients
3 secondary outcomes
total intubation time taken
Time frame: half an hour
glottic injury and cuff damages during tube advanced
Time frame: half an hour
postoperative nasal bleeding, sore throat and hoarseness
Time frame: 2 days
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 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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, 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 Magill forceps and cuff inflation 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 7 Nov 2023. 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?
the technique spending time in this time interval and first attempt successful rate (time frame: 10 minutes). 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 7 Nov 2023.