Intubation, IntratrachealTEENCT02034643
Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure
A study testing balloon pressure adjustment in people with Intubation, Intratracheal, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- balloon pressure adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Jan 2014
- 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
- adult patients scheduled for elective cardiothoracic surgery
- requiring intraoperative TEE monitoring
Who cannot join
- patients with tracheal stenosis
- patients with tracheoesophageal fistula
- patients with esophageal surgery
- patients with esophageal varix
- patients with Barrett esophagus
- patients with esophageal hernia
Show all 9Show fewer
- patients with descending thoracic aorta aneurysm
- patients with dysphagia
- patients with vocal fold palsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increase of Tracheal Cuff Pressure During Transesophageal Echocardiography Probe Insertion: Double-lumen Tube Versus Single-lumen Tube
Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and double-lumen tube.
- Conditions
- Intubation, Intratracheal
- Being tested
- balloon pressure adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon pressure adjustmentProcedure or surgery
Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion
| Study group | Role | What they receive |
|---|---|---|
| patients with single-lumen tube | Other | Patients who required intraoperative TEE and single-lumen tube; balloon pressure adjustment before TEE probe insertion Receives: Procedure: balloon pressure adjustment |
| patients with double-lumen tube | Other | Patients who required intraoperative TEE and double-lumen tube; balloon pressure adjustment before TEE probe insertion Receives: Procedure: balloon pressure adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal cuff pressure
Measured: 1 min after TEE probe insertion
Secondary outcomes (1)
Tracheal cuff pressure
Measured: every min for 5 min after TEE probe insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
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 Intubation, IntratrachealStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034643
- Sponsor's protocol ID
- YSJeon_Cuff
- Acronym
- TEE
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Publications
Kim TK, Min JJ, Seo JH, Lee YH, Ju JW, Bahk JH, Hong DM, Jeon Y. Increased tracheal cuff pressure during insertion of a transoesophageal echocardiography probe: A prospective, observational study. Eur J Anaesthesiol. 2015 Aug;32(8):549-54. doi: 10.1097/EJA.0000000000000204.
PubMed 25564781
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increase of Tracheal Cuff Pressure During Transesophageal Echocardiography Probe Insertion: Double-lumen Tube Versus Single-lumen Tube
- ClinicalTrials.gov ID
- NCT02034643
- Acronym / sponsor ID
- TEE / YSJeon_Cuff
- Conditions
- Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Jan 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.
Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and double-lumen tube.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with single-lumen tube | Other | Procedure: balloon pressure adjustmentPatients who required intraoperative TEE and single-lumen tube; balloon pressure adjustment before TEE probe insertion |
| patients with double-lumen tube | Other | Procedure: balloon pressure adjustmentPatients who required intraoperative TEE and double-lumen tube; balloon pressure adjustment before TEE probe insertion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients scheduled for elective cardiothoracic surgery
- requiring intraoperative TEE monitoring
Key exclusion criteria (9 listed)
- patients with tracheal stenosis
- patients with tracheoesophageal fistula
- patients with esophageal surgery
- patients with esophageal varix
- patients with Barrett esophagus
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 |
|---|---|---|
| balloon pressure adjustmentTracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion | Procedure or surgery | patients with double-lumen tube, patients with single-lumen tube |
Primary outcome
Tracheal cuff pressure
Time frame: 1 min after TEE probe insertion
1 secondary outcome
Tracheal cuff pressure
Time frame: every min for 5 min after TEE probe insertion
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 17 Sep 2014.
- Derived from this study: PubMed 25564781Kim TK, Min JJ, Seo JH, Lee YH, Ju JW, Bahk JH, Hong DM, Jeon Y. Increased tracheal cuff pressure during insertion of a transoesophageal echocardiography probe: A prospective, observational study. Eur J Anaesthesiol. 2015 Aug;32(8):549-54. doi: 10.1097/EJA.0000000000000204.
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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 balloon pressure adjustment in people with Intubation, Intratracheal, 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 2 inclusion and 9 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 17 Sep 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?
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?
Tracheal cuff pressure (time frame: 1 min after TEE probe insertion). 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 NCT02034643, 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 Sep 2014.