IntubationNCT01997541
Insertion Depth Comparison of Tracheal Tubes
An observational study of Intubation, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial summary
There will be a difference of the insertion depth between the types of the endotracheal tube. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Oct 2013
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: American Society of Anesthesiologists physical status I, II patients scheduled for elective surgery with general anesthesia
Who may be able to join
- undergoing surgery under general anesthesia -
Who cannot join
- upper airway or pulmonary problems
- neck and/or chest distortion
- patients at risk for pulmonary aspiration of gastric content -
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul, 134-090
About this study
There will be a difference of the insertion depth between the types of the endotracheal tube.
- Conditions
- Intubation
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 |
|---|---|---|
| plain tube | Not described | |
| reinforced tube | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the distance between endotracheal tube tip and carina
Measured: within 1 minute after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Man Kang, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997541
- Sponsor's protocol ID
- Kang528
- Status last verified
- Nov 2013
- First submitted
- 15 Jul 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion Depth Comparison of Tracheal Tubes
- ClinicalTrials.gov ID
- NCT01997541
- Acronym / sponsor ID
- Kang528
- Conditions
- Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Nov 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.
There will be a difference of the insertion depth between the types of the endotracheal tube.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plain tube | – | – |
| reinforced tube | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- American Society of Anesthesiologists physical status I, II patients scheduled for elective surgery with general anesthesia
Key inclusion criteria (1 listed)
- undergoing surgery under general anesthesia -
Key exclusion criteria (3 listed)
- upper airway or pulmonary problems
- neck and/or chest distortion
- patients at risk for pulmonary aspiration of gastric content -
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
the distance between endotracheal tube tip and carina
Time frame: within 1 minute after intubation
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 28 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
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 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 28 Nov 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 South Korea. 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 distance between endotracheal tube tip and carina (time frame: within 1 minute after intubation). 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 28 Nov 2013.