Anesthesia Intubation ComplicationsNCT01517204
The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube
A study testing Direct laryngoscope (Macintoish laryngoscope) and Trachway(R) intubating stylet in people with Anesthesia Intubation Complications, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation 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
- Anesthesia Intubation Complications
- What is being tested?
- Direct laryngoscope (Macintoish laryngoscope) and Trachway(R) intubating stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2011to May 2012
- 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
department of anesthesia, Kaohsiung medical university memorial hospital
Kaohsiung City, Kaohsiung, 807
About this study
Official title: The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube
The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.
Read the detailed description
Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.
The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.
- Conditions
- Anesthesia Intubation Complications
- Being tested
- Direct laryngoscope (Macintoish laryngoscope), Trachway(R) intubating stylet
- Keywords
- Trachway(R) intubating stylet, Left sided double lumen endobronchial tube, Efficacy, Intubation complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscope (Macintoish laryngoscope)Device
Also called Macintoish laryngoscope
Direct laryngoscope was used to facilitate the intubation of left-sided DLT.
Trachway(R) intubating styletDevice
Also called The Clarus Video System
Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.
| Study group | Role | What they receive |
|---|---|---|
| Direct laryngoscope | Experimental | Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube. Receives: Device: Direct laryngoscope (Macintoish laryngoscope) |
| Trachway(R) intubating stylet | Experimental | Trachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation. Receives: Device: Trachway(R) 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 intubation
Measured: 12 month
Secondary outcomes (6)
The outcome measure is the time needed to insert the DLT
Measured: 12 months
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 months
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 months
The outcome measure is the incidence of hypoxemia.
Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.
Measured: 12 months
The outcome measure is the incidence of sore throat.
Sore throat was observed and evaluated after extubation and patient regained consciousness.
Measured: 12 months
The outcome measure is the incidence of hoarseness.
Hoarseness was observed and evaluated after extubation and patient regained consciousness.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationsStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Te Hsu, VS, Principal investigator, Department of anesthesia, Kaoshiung medical university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517204
- Sponsor's protocol ID
- KMUH-IRB-990305
- Status last verified
- May 2011
- First submitted
- 15 Nov 2011
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube
- ClinicalTrials.gov ID
- NCT01517204
- Acronym / sponsor ID
- KMUH-IRB-990305
- Conditions
- Anesthesia Intubation Complications
- Keywords
- Trachway(R) intubating stylet, Left sided double lumen endobronchial tube, Efficacy, Intubation complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Jan 2012 (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 investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.
Detailed description
Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.
The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct laryngoscope | Experimental | Device: Direct laryngoscope (Macintoish laryngoscope)Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube. |
| Trachway(R) intubating stylet | Experimental | Device: Trachway(R) intubating styletTrachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation. |
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 |
|---|---|---|
| Direct laryngoscope (Macintoish laryngoscope)Also: Macintoish laryngoscopeDirect laryngoscope was used to facilitate the intubation of left-sided DLT. | Device | Direct laryngoscope |
| Trachway(R) intubating styletAlso: The Clarus Video SystemTrachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT. | Device | Trachway(R) intubating stylet |
Primary outcome
Main outcome measure is the successful rate of the first intubation
Time frame: 12 month
6 secondary outcomes
The outcome measure is the time needed to insert the DLT
Time frame: 12 months
The outcome measure is mean blood pressure (MAP) during intubation period
Time frame: 12 months
The outcome measure is the heart rate (HR) during intubation period
Time frame: 12 months
The outcome measure is the incidence of hypoxemia.
Time frame: 12 months
The outcome measure is the incidence of sore throat.
Time frame: 12 months
The outcome measure is the incidence of hoarseness.
Time frame: 12 months
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 Sep 2012.
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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, VS principal investigator
Department of anesthesia, Kaoshiung medical 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 Direct laryngoscope (Macintoish laryngoscope) and Trachway(R) intubating stylet in people with Anesthesia Intubation Complications, 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 Sep 2012. 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. 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 intubation (time frame: 12 month). 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 18 Sep 2012.