IntubationLateralCuffNCT02165319
The Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change
A study testing Barrel and Tapered in people with Intubation and Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation, Pain, Pharyngitis
- What is being tested?
- Barrel and Tapered
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Feb 2015
- 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
- Patient scheduled for nephrectomy in lateral decubitus position
Who cannot join
- Pregnancy
- Patients with difficult airway
- Patients with neck motion disorder
- Patients with history of neck surgery
- Patients with history of oral and pharyngeal surgery
- Patients with body mass index > 35
- Patients without teeth
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul
Hee-Pyoung Park, PhD, 82-2-2072-2365, hppark@snu.ac.kr
Hyun-Chang Kim, MD
About this study
Official title: Comparison of the Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change: Barrel-shaped vs. Taper-shaped Cuff
To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff
Read the detailed description
The position of endotracheal tubes depends on the position of the patients. The change of the tube's position is known to influence the pressure of tube's cuff. The shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force.
The investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.
- Conditions
- Intubation, Pain, Pharyngitis, Hoarseness, Cough
- Being tested
- Barrel, Tapered
- Medical subject headings
- Pain, Pharyngitis, Hoarseness, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarrelDevice
Barrel-shaped endotracheal tube will be used during general anesthesia.
TaperedDevice
Tapered-shaped tube will be used during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Barrel | Active comparator | Endotracheal tube with barrel-shaped cuff will be used during general anesthesia. Receives: Device: Barrel |
| Tapered | Active comparator | Endotracheal tube with tapered-shaped cuff will be used during general anesthesia. Receives: Device: Tapered |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cuff pressure after supine-to-lateral position change
The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®.
Measured: At 10 minutes after anesthetic induction
Secondary outcomes (2)
The distance from the tube to the carina
The distance from the tube to the carina will be measured using bronchoscopy after supine-to-lateral position change.
Measured: At 10 minutes after anesthetic induction
Complications related to endotracheal tube
Complications related to endotracheal tube (sore throat, hoarseness, dysphagia and cough) will be measured as 0:none, 1:mild, 2:moderate, 3:severe at 0, 2, and 24 hours postoperatively.
Measured: At 0, 2, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee-Pyoung Park, PhD, Principal investigator, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165319
- Sponsor's protocol ID
- LateralTaperedCuff-phpkhc
- Other IDs
- LateralCuff_SNUH
- Acronym
- LateralCuff
- Status last verified
- Jun 2014
- First submitted
- 27 May 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HC, Lee YH, Kim E, Oh EA, Jeon YT, Park HP. Comparison of the endotracheal tube cuff pressure between a tapered- versus a cylindrical-shaped cuff after changing from the supine to the lateral flank position. Can J Anaesth. 2015 Oct;62(10):1063-70. doi: 10.1007/s12630-015-0394-z. Epub 2015 Apr 17.
PubMed 25894912
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change: Barrel-shaped vs. Taper-shaped Cuff
- ClinicalTrials.gov ID
- NCT02165319
- Acronym / sponsor ID
- LateralCuff / LateralTaperedCuff-phpkhc
- Conditions
- Intubation, Pain, Pharyngitis, Hoarseness, Cough
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 17 Jun 2014 (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.
To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff
Detailed description
The position of endotracheal tubes depends on the position of the patients. The change of the tube's position is known to influence the pressure of tube's cuff. The shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force.
The investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barrel | Active comparator | Device: BarrelEndotracheal tube with barrel-shaped cuff will be used during general anesthesia. |
| Tapered | Active comparator | Device: TaperedEndotracheal tube with tapered-shaped cuff will be used during general anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient scheduled for nephrectomy in lateral decubitus position
Key exclusion criteria (7 listed)
- Pregnancy
- Patients with difficult airway
- Patients with neck motion disorder
- Patients with history of neck surgery
- Patients with history of oral and pharyngeal surgery
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 |
|---|---|---|
| BarrelBarrel-shaped endotracheal tube will be used during general anesthesia. | Device | Barrel |
| TaperedTapered-shaped tube will be used during general anesthesia. | Device | Tapered |
Primary outcome
The cuff pressure after supine-to-lateral position change
Time frame: At 10 minutes after anesthetic induction
The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®.
2 secondary outcomes
The distance from the tube to the carina
Time frame: At 10 minutes after anesthetic induction
Complications related to endotracheal tube
Time frame: At 0, 2, and 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Derived from this study: PubMed 25894912Kim HC, Lee YH, Kim E, Oh EA, Jeon YT, Park HP. Comparison of the endotracheal tube cuff pressure between a tapered- versus a cylindrical-shaped cuff after changing from the supine to the lateral flank position. Can J Anaesth. 2015 Oct;62(10):1063-70. doi: 10.1007/s12630-015-0394-z. Epub 2015 Apr 17.
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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.
Hee-Pyoung Park, PhD principal investigator
Seoul National University of 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 Barrel and Tapered in people with Intubation and Pain, run by Seoul 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 7 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 17 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Chang Kim, MD (+821028862876, onidori1979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cuff pressure after supine-to-lateral position change (time frame: At 10 minutes after anesthetic induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165319, which also lists 1 linked publication.
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 17 Jun 2014.