Cuff PressureNCT02797938
Comparison of the Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube
A study testing Taper guard tube and Cylindrical tube in people with Cuff Pressure, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cuff Pressure
- What is being tested?
- Taper guard tube and Cylindrical 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
- Jun 2016to Jul 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent middle ear surgery with general anesthesia American Society of Anesthesiology status 1-3
Who cannot join
- Patient with neck pain Patient with a history of neck surgery Patient with limited movement of neck Patient with body mass index more than 35
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 Tube and a Cylindrical-shaped Cuffed Tube After Changing in Position During Middle Ear Surgery
Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. The change of cuff pressure was compared between two groups
Read the detailed description
Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/O2 and remifentanil. The cuff pressure was initially set at 24 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. In addition, sore throat, hoarseness , dysphagia and cough were recorded 0, 6, 12, 24 hr after surgery. The change of cuff pressure was compared between two groups. The side effects associated with tube were compared between two groups.
- Conditions
- Cuff Pressure
- Being tested
- Taper guard tube, Cylindrical tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taper guard tubeDevice
Taper guard tube was intubated
Cylindrical tubeDevice
Cylindrical tube was intubated
| Study group | Role | What they receive |
|---|---|---|
| Taper guard tube | Experimental | Taper guard tube was intubated in 26 patients Receives: Device: Taper guard tube |
| Cylindrical tube | Active comparator | Cylindrical tube was intubated in 26 patients Receives: Device: Cylindrical tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cuff pressure
Change of cuff pressure of endotracheal tube after rotation 45 degree of head
Measured: 5 minutes after rotation of 45 degree of head
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff PressureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797938
- Sponsor's protocol ID
- KNUH 2016-02-017-001
- Status last verified
- Jan 2017
- First submitted
- 9 Jun 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. 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 Tube and a Cylindrical-shaped Cuffed Tube After Changing in Position During Middle Ear Surgery
- ClinicalTrials.gov ID
- NCT02797938
- Acronym / sponsor ID
- KNUH 2016-02-017-001
- Conditions
- Cuff Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Jun 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.
Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. The change of cuff pressure was compared between two groups
Detailed description
Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/O2 and remifentanil. The cuff pressure was initially set at 24 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. In addition, sore throat, hoarseness , dysphagia and cough were recorded 0, 6, 12, 24 hr after surgery. The change of cuff pressure was compared between two groups. The side effects associated with tube were compared between two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taper guard tube | Experimental | Device: Taper guard tubeTaper guard tube was intubated in 26 patients |
| Cylindrical tube | Active comparator | Device: Cylindrical tubeCylindrical tube was intubated in 26 patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent middle ear surgery with general anesthesia American Society of Anesthesiology status 1-3
Key exclusion criteria (1 listed)
- Patient with neck pain Patient with a history of neck surgery Patient with limited movement of neck Patient with body mass index more than 35
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 |
|---|---|---|
| Taper guard tubeTaper guard tube was intubated | Device | Taper guard tube |
| Cylindrical tubeCylindrical tube was intubated | Device | Cylindrical tube |
Primary outcome
Change of cuff pressure
Time frame: 5 minutes after rotation of 45 degree of head
Change of cuff pressure of endotracheal tube after rotation 45 degree of head
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 31 Jan 2017.
- Individual participant dataSharing planned: Yes
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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?
A study testing Taper guard tube and Cylindrical tube in people with 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 31 Jan 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 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?
Change of cuff pressure (time frame: 5 minutes after rotation of 45 degree of head). 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 Jan 2017.