Intubation ComplicationNCT04735250
Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation
An observational study of Intubation Complication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation Complication
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Aug 2020to 31 Jul 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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
Study population: Adult(20 to 65 years old)
Who may be able to join
- undergoing surgery with general anesthesia(GA)
- ASA(American Society of Anesthesiologists):Ι to III
- 20 to 65 years old
- mouth Open > 3 cm
- the systemic disease exclusion
- conscious clear and without major Neurocognitive Disorder
- Mandarin or Taiwanese speaker
- agree the purpose of the study and sign the ICF
Who cannot join
- difficult airway assessment [limited mouth opening < 3cm, limited neck motion(thyromental distance < 6cm)]
- previous head neck surgery history, oral and respiratory tract tumors, oral infections, neck disease, loosen tooth
- morbid obesity
- reject to participate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin District, 807
Chia-Heng Lin, MD, 88673121101 ext. 7035, linsofar@yahoo.com.tw
About this study
Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea
Read the detailed description
In the patients receiving general anesthesia with nasotracheal or orotracheal intubation is common. However, a orotracheal tube blindly passing through the oral cavity and oropharynx may easily result in oral cavity and oropharynx damages.
The advancement of the tube from oropharynx into trachea may assist using the video stylet.
The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the orotracheal tube passing the oral cavity, oropharynx, and advanced into the trachea.
Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate orotracheal tube sliding through into trachea and compared with each other group. Hemodynamic changes in each time interval, each time taken of tube going through the oral cavity, tube advanced from oropharynx into trachea will be recorded.
The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.
- Conditions
- Intubation Complication
- Keywords
- video stylet, angulation, orotracheal Intubation, trachway, tracheal intubation, Endotracheal Tube intubation General Anesthesia (ETGA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 45° group | Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea | |
| 70° group | Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea | |
| 90° group | Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of video stylet angulation and successful first tube attempt in 60 seconds
successful rate of the properly video stylet angulation passing through oral cavity into trachea.
Time: TTI(time taken advancement) is less than 60 seconds in first tube attempt, it defines successful; TTI(time taken advancement) is over 60 seconds in first tube attempt, it defines unsuccessful.
Measured: During procedure
success rate of video stylet angulation and successful first tube attempt in Lung's ventilation
successful rate of the properly video stylet angulation passing through oral cavity into trachea.
Lung's ventilation: The lung's ventilation is success.
Measured: During procedure
time taken advancement(TTI)
time taken advancement from oral cavity into trachea in each time interval
Measured: During procedure
assessment of difficult intubation(IDS)
Assessment of difficult intubation by Intubation Difficulty Scale(The Intubation Difficulty Scale, IDS, 1997) is required after intubation. Number of Attempts>1, score "N1"; Number of Operators >1, score "N2"; Number of Alternative Techniques, score "N3"; Comark Grade -1, score "N4"; Lifting Force Required Normal, score "N5=0"; Lifting Force Required Increased, score "N5=1"; Laryngeal Pressure Not applied, score "N6=0"; Laryngeal Pressure Applied, score "N6=1"; Vocal Cord Mobility Abducion, score "N7=0"; Vocal Cord Mobility Adducion, score "N7=1". IDS=Sum of scores(N1-N7). If IDS score gains "0" means "Easy", "0<IDS≤5" means "Slight Difficulty", "5<IDS" means "Moderate to Major Difficulty", "IDS=∞" means "Impossible intubation".
Measured: During procedure
assessment of Glottic grade(Cormack Grade)
Assessment of Glottic grade(Cormack Grade) is required after intubation. The definitions of grade: Grade 1: full view of the glottis; Grade 2a: partial view of the glottis; Grade 2b: arytenoids only; Grade 3: epiglottis only; Grade 4: neither glottis or epiglottis identified
Measured: During procedure
Secondary outcomes (1)
post-intubation induced oropharyngeal bleeding, hoarseness and sore throat
A visiting questionnaire is used to measure the condition of post-intubation, including oropharyngeal bleeding, sore throat, hoarseness, dysphagia. The score for the measurement of oropharyngeal bleeding, sore throat, hoarseness, dysphagia is divided into four degrees: none, mild, moderate and severe. All the evaluation will be assessed in the next coming morning after the postoperation.
Measured: Day 2(the day after the operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start25 Aug 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Heng Lin, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Chia-Heng Lin, MD, Principal investigator, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735250
- Sponsor's protocol ID
- KMUHIRB-F(II)-20200132
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation
- ClinicalTrials.gov ID
- NCT04735250
- Acronym / sponsor ID
- KMUHIRB-F(II)-20200132
- Conditions
- Intubation Complication
- Keywords
- video stylet, angulation, orotracheal Intubation, trachway, tracheal intubation, Endotracheal Tube intubation General Anesthesia (ETGA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 3 Feb 2021 (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.
Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea
Detailed description
In the patients receiving general anesthesia with nasotracheal or orotracheal intubation is common. However, a orotracheal tube blindly passing through the oral cavity and oropharynx may easily result in oral cavity and oropharynx damages.
The advancement of the tube from oropharynx into trachea may assist using the video stylet.
The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the orotracheal tube passing the oral cavity, oropharynx, and advanced into the trachea.
Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate orotracheal tube sliding through into trachea and compared with each other group. Hemodynamic changes in each time interval, each time taken of tube going through the oral cavity, tube advanced from oropharynx into trachea will be recorded.
The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 45° group | – | –Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea |
| 70° group | – | –Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea |
| 90° group | – | –Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°) to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult(20 to 65 years old)
Key inclusion criteria (8 listed)
- undergoing surgery with general anesthesia(GA)
- ASA(American Society of Anesthesiologists):Ι to III
- 20 to 65 years old
- mouth Open > 3 cm
- the systemic disease exclusion
Key exclusion criteria (4 listed)
- difficult airway assessment [limited mouth opening < 3cm, limited neck motion(thyromental distance < 6cm)]
- previous head neck surgery history, oral and respiratory tract tumors, oral infections, neck disease, loosen tooth
- morbid obesity
- reject to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
success rate of video stylet angulation and successful first tube attempt in 60 seconds
Time frame: During procedure
successful rate of the properly video stylet angulation passing through oral cavity into trachea. Time: TTI(time taken advancement) is less than 60 seconds in first tube attempt, it defines successful; TTI(time taken advancement) is over 60 seconds in first tube attempt, it defines unsuccessful.
success rate of video stylet angulation and successful first tube attempt in Lung's ventilation
Time frame: During procedure
successful rate of the properly video stylet angulation passing through oral cavity into trachea. Lung's ventilation: The lung's ventilation is success.
time taken advancement(TTI)
Time frame: During procedure
time taken advancement from oral cavity into trachea in each time interval
assessment of difficult intubation(IDS)
Time frame: During procedure
Assessment of difficult intubation by Intubation Difficulty Scale(The Intubation Difficulty Scale, IDS, 1997) is required after intubation. Number of Attempts>1, score "N1"; Number of Operators >1, score "N2"; Number of Alternative Techniques, score "N3"; Comark Grade -1, score "N4"; Lifting Force Required Normal, score "N5=0"; Lifting Force Required Increased, score "N5=1"; Laryngeal Pressure Not applied, score "N6=0"; Laryngeal Pressure Applied, score "N6=1"; Vocal Cord Mobility Abducion, score "N7=0"; Vocal Cord Mobility Adducion, score "N7=1". IDS=Sum of scores(N1-N7). If IDS score gains "0" means "Easy", "0<IDS≤5" means "Slight Difficulty", "5<IDS" means "Moderate to Major Difficulty", "IDS=∞" means "Impossible intubation".
assessment of Glottic grade(Cormack Grade)
Time frame: During procedure
Assessment of Glottic grade(Cormack Grade) is required after intubation. The definitions of grade: Grade 1: full view of the glottis; Grade 2a: partial view of the glottis; Grade 2b: arytenoids only; Grade 3: epiglottis only; Grade 4: neither glottis or epiglottis identified
1 secondary outcome
post-intubation induced oropharyngeal bleeding, hoarseness and sore throat
Time frame: Day 2(the day after the operation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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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.
Chia-Heng Lin, MD principal investigator
Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 8 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: status not confirmed, as of the sponsor's last update on 3 Feb 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 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 Chia-Heng Lin, MD (88673121101 ext. 7035, linsofar@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of video stylet angulation and successful first tube attempt in 60 seconds (time frame: During procedure). The study lists 5 primary outcomes in all. 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 3 Feb 2021.