Endotracheal TubeNCT04503031
Comparison of Nasal Taper-guard Cuffed and a Nasal Cylindrical Endotracheal Tube
A study testing TaperGuard endotracheal tube and cylindrical endotracheal tube in people with Endotracheal Tube and Cuff Pressure, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endotracheal Tube, Cuff Pressure
- What is being tested?
- TaperGuard endotracheal tube and cylindrical endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2020to 1 Aug 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient who were underwent nasal intubation
Who cannot join
- history of difficult intubation, limited neck movement, respiratory diseases and body mass index more than 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Nasal Endotracheal Tube and a Cylindrical-shaped Cuffed Nasal Endotracheal Tube After Changing in Position of Head
This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.
Read the detailed description
The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff pressure and distance from endotracheal tube tip to carina during study period.This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.
- Conditions
- Endotracheal Tube, Cuff Pressure
- Being tested
- TaperGuard endotracheal tube, cylindrical endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaperGuard endotracheal tubeDevice
TaperGuard endotracheal tube is intubated
cylindrical endotracheal tubeDevice
endotracheal tube is intubated
| Study group | Role | What they receive |
|---|---|---|
| cylindrical tube group | Active comparator | The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube. Receives: Device: cylindrical endotracheal tube |
| tapergaurd tube group | Experimental | The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube. Receives: Device: TaperGuard endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff pressure
Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany).
Measured: 5 minutes after change of head position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start10 Jan 2020
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal TubeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
- Investigators
- Younghoon Jeon, Mr, Principal investigator, kyungook national university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503031
- Sponsor's protocol ID
- 2019-11-043-001
- Status last verified
- Oct 2020
- First submitted
- 3 Aug 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Nasal Endotracheal Tube and a Cylindrical-shaped Cuffed Nasal Endotracheal Tube After Changing in Position of Head
- ClinicalTrials.gov ID
- NCT04503031
- Acronym / sponsor ID
- 2019-11-043-001
- Conditions
- Endotracheal Tube, Cuff Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 6 Aug 2020 (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.
This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.
Detailed description
The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff pressure and distance from endotracheal tube tip to carina during study period.This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cylindrical tube group | Active comparator | Device: cylindrical endotracheal tubeThe patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube. |
| tapergaurd tube group | Experimental | Device: TaperGuard endotracheal tubeThe patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who were underwent nasal intubation
Key exclusion criteria (1 listed)
- history of difficult intubation, limited neck movement, respiratory diseases and body mass index more than 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 |
|---|---|---|
| TaperGuard endotracheal tubeTaperGuard endotracheal tube is intubated | Device | tapergaurd tube group |
| cylindrical endotracheal tubeendotracheal tube is intubated | Device | cylindrical tube group |
Primary outcome
Cuff pressure
Time frame: 5 minutes after change of head position
Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany).
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 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Younghoon Jeon, Mr principal investigator
kyungook national university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaperGuard endotracheal tube and cylindrical endotracheal tube in people with Endotracheal Tube and Cuff Pressure, run by Kyungpook National University Hospital 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 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: finished, as of the sponsor's last update on 28 Oct 2020. 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?
Cuff pressure (time frame: 5 minutes after change of head position). 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 Oct 2020.