ThyroidectomyNCT02949856
E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck
A study testing Mallinckrodt, COVIDIEN and Endotracheal tube, Unomedica in people with Thyroidectomy, run by Keimyung University Dongsan Medical Center.
Trial summary
This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck. Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- Mallinckrodt, COVIDIEN and Endotracheal tube, Unomedica
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jul 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy
Who cannot join
- difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endotracheal Tube Intracuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck - Comparison of a Tapered Shaped- and Cylindrical Shaped Cuff
This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.
Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.
- Conditions
- Thyroidectomy
- Being tested
- Mallinckrodt, COVIDIEN, Endotracheal tube, Unomedica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mallinckrodt, COVIDIENDevice
Endotracheal tube, UnomedicaDevice
| Study group | Role | What they receive |
|---|---|---|
| Tapered | Experimental | Mallinckrodt, COVIDIEN Receives: Device: Mallinckrodt, COVIDIEN |
| Cylindrical | Active comparator | Endotracheal tube, Unomedical Receives: Device: Endotracheal tube, Unomedica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intracuff pressure
Measured: 1 year
Secondary outcomes (1)
Change in distance from carina to tip of tube
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong-Cheol Lee, MD, PhD, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949856
- Sponsor's protocol ID
- 2016-05-032-001
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Tube Intracuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck - Comparison of a Tapered Shaped- and Cylindrical Shaped Cuff
- ClinicalTrials.gov ID
- NCT02949856
- Acronym / sponsor ID
- 2016-05-032-001
- Conditions
- Thyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 31 Oct 2016 (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.
This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.
Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tapered | Experimental | Device: Mallinckrodt, COVIDIENMallinckrodt, COVIDIEN |
| Cylindrical | Active comparator | Device: Endotracheal tube, UnomedicaEndotracheal tube, Unomedical |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy
Key exclusion criteria (1 listed)
- difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity
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 |
|---|---|---|
| Mallinckrodt, COVIDIEN | Device | Tapered |
| Endotracheal tube, Unomedica | Device | Cylindrical |
Primary outcome
Change in intracuff pressure
Time frame: 1 year
1 secondary outcome
Change in distance from carina to tip of tube
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- 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.
Yong-Cheol Lee, MD, PhD principal investigator
Keimyung University Dongsan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Mallinckrodt, COVIDIEN and Endotracheal tube, Unomedica in people with Thyroidectomy, run by Keimyung University Dongsan Medical Center.
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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Yong-Cheol Lee, MD, PhD (82-53-250-7193, yclee@dsmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intracuff pressure (time frame: 1 year). 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 31 Oct 2016.