Airway Complication of AnesthesiaTTNCT03366311
TCHCCT-Zhong-Xing-Emergency-Department-airway
A study testing holding position in people with Airway Complication of Anesthesia and Intubation;Difficult, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
To investigate which shapes of stylet, hand techniques and possible condition that improve intubation successful rate and reduce the elapsed intubation time. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia, Intubation;Difficult
- What is being tested?
- holding position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2017to 30 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- care givers with sufficient understanding of airway anatomy and management
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital Zhong-Xing branch
Taipei, 100
Tzu-Yao Hung, MD, 886-2-979305599
About this study
Official title: TCH-Zhong-Xing-Branch-Emergency-Department
To investigate which shapes of stylet, hand techniques and possible condition that improve intubation successful rate and reduce the elapsed intubation time.
Read the detailed description
Challenging airway is always a big issue in emergency room. However, better hand technique, stylet shapes and conditions affecting intubation successful rate, elapsed duration need further investigations. We compare two endotracheal tube holding position, two holding places, with or without epiglottis lift technique in this study. All intubation processes in the study will be recorded.
- Being tested
- holding position
- Keywords
- intubation, epiglottis lift, hold high position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holding positionProcedure or surgery
Also called shapes of stylet, epiglottis lift
two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
| Study group | Role | What they receive |
|---|---|---|
| holding position | Active comparator | different holding position of endotracheal tube Receives: Procedure: holding position |
| stylet shapes | Active comparator | banana shape versus straight-to-cuff shape Receives: Procedure: holding position |
| epiglottis lift | Active comparator | with epiglottis lift or without Receives: Procedure: holding position |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation successful rate
intubation more than 90 seconds considered as a failed intubation
Measured: through study completion, and average of 15minutes
Secondary outcomes (3)
intubation elapsed time
from insertion of endotracheal to the tube until proper placement of endotracheal tube
Measured: through study completion, and average of 15minutes
insertion elapsed time
from proper glottic view to the tube until proper placement of endotracheal tube
Measured: through study completion, and average of 15minutes
difficulty of intubation
Visual Analogue Scale with a 10cm bar
Measured: through study completion, and average of 15minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start27 Nov 2017
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2019 (estimated)
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 Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Prospective randomised crossover manikin study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hung,Tzu-Yao, Taipei City Hospital
- Investigators
- Tzu-Yao Hung, MD, Study director, Taipei City Hospital ZhongXing Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366311
- Sponsor's protocol ID
- TCHCCT-ZXER
- Acronym
- TT
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hung TY, Lin LW, Yeh YH, Su YC, Lin CH, Yang TF. The evaluation of a better intubation strategy when only the epiglottis is visible: a randomized, cross-over mannequin study. BMC Anesthesiol. 2019 Jan 10;19(1):8. doi: 10.1186/s12871-018-0663-9.
PubMed 30630425
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCH-Zhong-Xing-Branch-Emergency-Department
- ClinicalTrials.gov ID
- NCT03366311
- Acronym / sponsor ID
- TT / TCHCCT-ZXER
- Keywords
- intubation, epiglottis lift, hold high position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 8 Dec 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 which shapes of stylet, hand techniques and possible condition that improve intubation successful rate and reduce the elapsed intubation time.
Detailed description
Challenging airway is always a big issue in emergency room. However, better hand technique, stylet shapes and conditions affecting intubation successful rate, elapsed duration need further investigations. We compare two endotracheal tube holding position, two holding places, with or without epiglottis lift technique in this study. All intubation processes in the study will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective randomised crossover manikin study
| Arm | Type | Receives |
|---|---|---|
| holding position | Active comparator | Procedure: holding positiondifferent holding position of endotracheal tube |
| stylet shapes | Active comparator | Procedure: holding positionbanana shape versus straight-to-cuff shape |
| epiglottis lift | Active comparator | Procedure: holding positionwith epiglottis lift or without |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- care givers with sufficient understanding of airway anatomy and management
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| holding positionAlso: shapes of stylet, epiglottis lifttwo types of holding positions plus two types of shapes of stylet, with or without epiglottis lift | Procedure or surgery | epiglottis lift, holding position, stylet shapes |
Primary outcome
intubation successful rate
Time frame: through study completion, and average of 15minutes
intubation more than 90 seconds considered as a failed intubation
3 secondary outcomes
intubation elapsed time
Time frame: through study completion, and average of 15minutes
insertion elapsed time
Time frame: through study completion, and average of 15minutes
difficulty of intubation
Time frame: through study completion, and average of 15minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Derived from this study: PubMed 30630425Hung TY, Lin LW, Yeh YH, Su YC, Lin CH, Yang TF. The evaluation of a better intubation strategy when only the epiglottis is visible: a randomized, cross-over mannequin study. BMC Anesthesiol. 2019 Jan 10;19(1):8. doi: 10.1186/s12871-018-0663-9.
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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.
Tzu-Yao Hung, MD study director
Taipei City Hospital ZhongXing Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing holding position in people with Airway Complication of Anesthesia and Intubation;Difficult, run by Taipei City 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 1 inclusion and 1 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 11 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Yao Hung, MD (886-979305599, bryansolitude@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation successful rate (time frame: through study completion, and average of 15minutes). 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 NCT03366311, 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 11 Dec 2017.