Intubation;DifficultNCT03173443
Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube
A study testing single lumen tube and bronchial blocker and double lumen tube in people with Intubation;Difficult, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- single lumen tube and bronchial blocker and double lumen tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2017to 26 Aug 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiology Physical status 1,2
Who cannot join
- abnormality of upper airway, gastroesophageal disease, risk of aspiration, BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Insertion Time Over Fiberoptic Bronchoscope Between Double Lumen Tube and Single Lumen Tube
One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT.
The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.
- Conditions
- Intubation;Difficult
- Being tested
- single lumen tube and bronchial blocker, double lumen tube
- Keywords
- Fiberoptic intubation, double lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single lumen tube and bronchial blockerDevice
fiberoptic intubation with single lumen tube and bronchial blocker
double lumen tubeDevice
fiberoptic intubation with double umen tube
| Study group | Role | What they receive |
|---|---|---|
| single lumen tube | Experimental | fiberoptic intubation with single lumen tube with bronchial blocker. Receives: Device: single lumen tube and bronchial blocker |
| double lumen tube | Experimental | fiberoptic intubation with double lumen tube. Receives: Device: double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertion time
time from insertion of bronchoscope into mouth to tube placement at trachea or bronchus
Measured: at anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start31 May 2017
- Primary completion26 Aug 2017
- Study completion26 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAE HEE KIM, Ajou University School of Medicine
- Investigators
- Dae Hee Kim, M.D., Principal investigator, Ajou unversity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173443
- Sponsor's protocol ID
- AJIRB-DEV-OBS-17-70
- Status last verified
- Jan 2018
- First submitted
- 30 May 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Insertion Time Over Fiberoptic Bronchoscope Between Double Lumen Tube and Single Lumen Tube
- ClinicalTrials.gov ID
- NCT03173443
- Acronym / sponsor ID
- AJIRB-DEV-OBS-17-70
- Conditions
- Intubation;Difficult
- Keywords
- Fiberoptic intubation, double lumen tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 26 Aug 2017 (actual)
- Study completion
- 26 Aug 2017 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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.
One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT.
The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single lumen tube | Experimental | Device: single lumen tube and bronchial blockerfiberoptic intubation with single lumen tube with bronchial blocker. |
| double lumen tube | Experimental | Device: double lumen tubefiberoptic intubation with double lumen tube. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiology Physical status 1,2
Key exclusion criteria (1 listed)
- abnormality of upper airway, gastroesophageal disease, risk of aspiration, BMI > 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 |
|---|---|---|
| single lumen tube and bronchial blockerfiberoptic intubation with single lumen tube and bronchial blocker | Device | single lumen tube |
| double lumen tubefiberoptic intubation with double umen tube | Device | double lumen tube |
Primary outcome
insertion time
Time frame: at anesthesia induction
time from insertion of bronchoscope into mouth to tube placement at trachea or bronchus
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 9 Jan 2018.
- 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.
Dae Hee Kim, M.D. principal investigator
Ajou unversity 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 single lumen tube and bronchial blocker and double lumen tube in people with Intubation;Difficult, run by Ajou University School of Medicine 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 9 Jan 2018. 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?
insertion time (time frame: at anesthesia induction). 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 9 Jan 2018.