Intubation ComplicationNCT02364622
The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube
A study testing Tranditional fiberoptic bronchoscopy, Modified fiberoptic bronchoscopy and Flexible Trachway intubating stylet in people with Intubation Complication and Intubation, Difficult, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation Complication, Intubation, Difficult
- What is being tested?
- Tranditional fiberoptic bronchoscopy, Modified fiberoptic bronchoscopy and Flexible Trachway intubating stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with American Society of Anesthesiologists physical status I-III
- More than 18 years of age
- Requiring DLT for thoracic surgery
Who cannot join
- risk of regurgitation and pulmonary aspiration
- history of gastroesophageal reflux, pregnancy
- scheduled tracheostomy and postoperative prolonged ventilation in ICU
- patients with limited neck extension (< 35°)
- a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
- a sternomental distance of less than 12.5 cm with the head fully extended
- mouth can not open
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 803
About this study
Official title: The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube
The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.
Read the detailed description
How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.
- Conditions
- Intubation Complication, Intubation, Difficult
- Being tested
- Tranditional fiberoptic bronchoscopy, Modified fiberoptic bronchoscopy, Flexible Trachway intubating stylet
- Keywords
- flexible intubating stylet, double-lumen endobronchial tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranditional fiberoptic bronchoscopyDevice
The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.
Modified fiberoptic bronchoscopyDevice
The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy
Flexible Trachway intubating styletDevice
The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.
| Study group | Role | What they receive |
|---|---|---|
| Tranditional fiberoptic bronchoscopy | Sham comparator | The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by traditional fiberoptic bronchoscopy. Receives: Device: Tranditional fiberoptic bronchoscopy |
| Modified fiberoptic bronchoscopy | Experimental | The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by modified fiberoptic bronchoscopy. Receives: Device: Modified fiberoptic bronchoscopy |
| Flexible Trachway intubating stylet | Experimental | We used Flexible Trachway intubating stylet to facilitate the accurate placement of left-sided double lumen endobronchial tube into the left main bronchus. Receives: Device: Flexible Trachway intubating stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea
Measured: 12 month
Secondary outcomes (6)
The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea
Measured: 12 month
The outcome measure is mean blood pressure (MAP) during intubation period
MAP was measured before intubation, and after intubation 1, 3,and 5 min.
Measured: 12 month
The outcome measure is the heart rate (HR) during intubation period
HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min
Measured: 12 month
The outcome measure is the incidence of hypoxemia
Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the intubation period.
Measured: 12 month
The outcome measure is the incidence of sore throat
Sore throat was observed and evaluated after extubation and patient regained consciousness
Measured: 12 month
The outcome measure is the incidence of hoarseness
Hoarseness was observed and evaluated after extubation and patient regained consciousness
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 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 ComplicationStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Te Hsu, MD, Principal investigator, Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364622
- Sponsor's protocol ID
- KMUH-IRB-20130194
- Status last verified
- Oct 2013
- First submitted
- 10 Feb 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hsu HT, Kuo YW, Ma CW, Su MP, Tseng KY, Li CL, Cheng KI. Trachway(R) flexible stylet facilitates the correct placement of double-lumen endobronchial tube: a prospective, randomized study. BMC Anesthesiol. 2022 Aug 15;22(1):260. doi: 10.1186/s12871-022-01800-8.
PubMed 35971080
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube
- ClinicalTrials.gov ID
- NCT02364622
- Acronym / sponsor ID
- KMUH-IRB-20130194
- Conditions
- Intubation Complication, Intubation, Difficult
- Keywords
- flexible intubating stylet, double-lumen endobronchial tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Feb 2015 (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 is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.
Detailed description
How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranditional fiberoptic bronchoscopy | Sham comparator | Device: Tranditional fiberoptic bronchoscopyThe accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by traditional fiberoptic bronchoscopy. |
| Modified fiberoptic bronchoscopy | Experimental | Device: Modified fiberoptic bronchoscopyThe accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by modified fiberoptic bronchoscopy. |
| Flexible Trachway intubating stylet | Experimental | Device: Flexible Trachway intubating styletWe used Flexible Trachway intubating stylet to facilitate the accurate placement of left-sided double lumen endobronchial tube into the left main bronchus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with American Society of Anesthesiologists physical status I-III
- More than 18 years of age
- Requiring DLT for thoracic surgery
Key exclusion criteria (7 listed)
- risk of regurgitation and pulmonary aspiration
- history of gastroesophageal reflux, pregnancy
- scheduled tracheostomy and postoperative prolonged ventilation in ICU
- patients with limited neck extension (< 35°)
- a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
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 |
|---|---|---|
| Tranditional fiberoptic bronchoscopyThe accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy. | Device | Tranditional fiberoptic bronchoscopy |
| Modified fiberoptic bronchoscopyThe accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy | Device | Modified fiberoptic bronchoscopy |
| Flexible Trachway intubating styletThe accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet. | Device | Flexible Trachway intubating stylet |
Primary outcome
Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea
Time frame: 12 month
6 secondary outcomes
The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea
Time frame: 12 month
The outcome measure is mean blood pressure (MAP) during intubation period
Time frame: 12 month
The outcome measure is the heart rate (HR) during intubation period
Time frame: 12 month
The outcome measure is the incidence of hypoxemia
Time frame: 12 month
The outcome measure is the incidence of sore throat
Time frame: 12 month
The outcome measure is the incidence of hoarseness
Time frame: 12 month
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 18 Feb 2015.
- Derived from this study: PubMed 35971080Hsu HT, Kuo YW, Ma CW, Su MP, Tseng KY, Li CL, Cheng KI. Trachway(R) flexible stylet facilitates the correct placement of double-lumen endobronchial tube: a prospective, randomized study. BMC Anesthesiol. 2022 Aug 15;22(1):260. doi: 10.1186/s12871-022-01800-8.
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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.
Hung-Te Hsu, MD principal investigator
Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial 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 Tranditional fiberoptic bronchoscopy, Modified fiberoptic bronchoscopy and Flexible Trachway intubating stylet in people with Intubation Complication and Intubation, Difficult, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 18 Feb 2015. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea (time frame: 12 month). 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 NCT02364622, 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 18 Feb 2015.