Cuff PressureNCT03040440
Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
A study testing Cylindrical endotracheal tube and TaperGaurd endotracheal tube in people with Cuff Pressure, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cuff Pressure
- What is being tested?
- Cylindrical endotracheal tube and TaperGaurd endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2016to 30 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants who were underwent laparoscopic cholecystectomy with American Society of Anesthesiologists physical status 1-3
Who cannot join
- history with respiratory disease, difficult intubation, and morbid obesity (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 Cuff Pressure of TaperGuard Endotracheal Tube and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.
Read the detailed description
Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured before and after abdominal insufflation in the supine position. After insufflation the head-up position (30°) was made and cuff pressure was recorded.
- Conditions
- Cuff Pressure
- Being tested
- Cylindrical endotracheal tube, TaperGaurd endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cylindrical endotracheal tubeDevice
Cylindrical endotracheal tube was intubated
TaperGaurd endotracheal tubeDevice
TaperGaurd endotracheal tube was intubated
| Study group | Role | What they receive |
|---|---|---|
| Cylindrical endotracheal tube | Active comparator | Cylindrical endotracheal tube was intubated in 32 participants Receives: Device: Cylindrical endotracheal tube |
| TaperGuard endotracheal tube | Experimental | TaperGuard endotracheal tube was intubated in 32 participants Receives: Device: TaperGaurd endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
cuff pressure
Measured: 5 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Jun 2016
- Primary completion15 Dec 2016
- Study completion30 Dec 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
- 64 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, MD, Study chair, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040440
- Sponsor's protocol ID
- KNUH 2016-03-001-004
- Status last verified
- Jan 2017
- First submitted
- 31 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cuff Pressure of TaperGuard Endotracheal Tube and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03040440
- Acronym / sponsor ID
- KNUH 2016-03-001-004
- Conditions
- Cuff Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 2 Feb 2017 (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.
The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.
Detailed description
Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured before and after abdominal insufflation in the supine position. After insufflation the head-up position (30°) was made and cuff pressure was recorded.
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 |
|---|---|---|
| Cylindrical endotracheal tube | Active comparator | Device: Cylindrical endotracheal tubeCylindrical endotracheal tube was intubated in 32 participants |
| TaperGuard endotracheal tube | Experimental | Device: TaperGaurd endotracheal tubeTaperGuard endotracheal tube was intubated in 32 participants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who were underwent laparoscopic cholecystectomy with American Society of Anesthesiologists physical status 1-3
Key exclusion criteria (1 listed)
- history with respiratory disease, difficult intubation, and morbid obesity (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 |
|---|---|---|
| Cylindrical endotracheal tubeCylindrical endotracheal tube was intubated | Device | Cylindrical endotracheal tube |
| TaperGaurd endotracheal tubeTaperGaurd endotracheal tube was intubated | Device | TaperGuard endotracheal tube |
Primary outcome
cuff pressure
Time frame: 5 minutes 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 2 Feb 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.
Younghoon Jeon, MD study chair
Kyungpook 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 Cylindrical endotracheal tube and TaperGaurd endotracheal 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 2 Feb 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?
cuff pressure (time frame: 5 minutes 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 2 Feb 2017.