Anesthesia Intubation ComplicationsNCT01605591
Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation
A study testing the DLT bending to the right and the DLT bending to the left 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 comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation. 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?
- the DLT bending to the right and the DLT bending to the left
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Aug 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
- American Society of Anesthesiologists physical status I-III
- more than 18 years of age
- Receiving thoracic surgery with double-lumen endobronchial tube
Who cannot join
- risk of regurgitation and pulmonary aspiration
- history of gastroesophageal reflux
- pregnancy
- scheduled tracheostomy and postoperative prolonged ventilation in ICU
- limited neck extension (< 35°)
- a thyromental distance less than 7 cm
- a sternomental distance 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
The purpose of this study is to comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation.
Read the detailed description
Intubation with the double-lumen endotracheal tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as GlideScope(R) videolaryngoscope, 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 different bending type of DLT in tracheal intubation.
- Conditions
- Anesthesia Intubation Complications
- Being tested
- the DLT bending to the right, the DLT bending to the left
- Keywords
- left-side double lumen bronchial tube, bending type, GlideScope videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the DLT bending to the rightProcedure or surgery
Also called different bending mode of DLT
bending the bronchial lumen of DLT 60~90 degrees in the same side with the tracheal lumen
the DLT bending to the leftProcedure or surgery
Also called different bending mode of DLT
bending the bronchial lumen of DLT 60~90 degree opposed to the tracheal lumen
| Study group | Role | What they receive |
|---|---|---|
| the DLT bending to the right | Active comparator | Not described Receives: Procedure: the DLT bending to the right |
| the DLT bending to the left | Active comparator | Not described Receives: Procedure: the DLT bending to the left |
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 compared with the two bending modes of DLT
Measured: 12 month
Secondary outcomes (6)
the time needed to insert the DLT during the period of intubation
Measured: 12 months
mean blood pressure (MAP) before intubation, and after intubation 1, 3,and 5 min
Measured: 12 months
the incidence of hypoxemia during the period of intubation
Hypoxemia is defined as the SPO2 is below 90%.
Measured: 12 months
the heart rate (HR) before intubation, and after intubation 1, 3,and 5 min
Measured: 12 months
the incidence of sore throat after extubation
Measured: 12 months
the incidence of hoarseness after extubation
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 May 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
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 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
- 66 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
- NCT01605591
- Sponsor's protocol ID
- KMUH-IRB-20110172
- Status last verified
- Sep 2014
- First submitted
- 16 Oct 2011
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu HT, Chou SH, Chou CY, Tseng KY, Kuo YW, Chen MC, Cheng KI. A modified technique to improve the outcome of intubation with a left-sided double-lumen endobronchial tube. BMC Anesthesiol. 2014 Aug 18;14:72. doi: 10.1186/1471-2253-14-72. eCollection 2014.
PubMed 25206313
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation
- ClinicalTrials.gov ID
- NCT01605591
- Acronym / sponsor ID
- KMUH-IRB-20110172
- Conditions
- Anesthesia Intubation Complications
- Keywords
- left-side double lumen bronchial tube, bending type, GlideScope videolaryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 May 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 comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation.
Detailed description
Intubation with the double-lumen endotracheal tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as GlideScope(R) videolaryngoscope, 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 different bending type of DLT in tracheal 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 |
|---|---|---|
| the DLT bending to the right | Active comparator | Procedure: the DLT bending to the right |
| the DLT bending to the left | Active comparator | Procedure: the DLT bending to the left |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I-III
- more than 18 years of age
- Receiving thoracic surgery with double-lumen endobronchial tube
Key exclusion criteria (8 listed)
- risk of regurgitation and pulmonary aspiration
- history of gastroesophageal reflux
- pregnancy
- scheduled tracheostomy and postoperative prolonged ventilation in ICU
- limited neck extension (< 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 |
|---|---|---|
| the DLT bending to the rightAlso: different bending mode of DLTbending the bronchial lumen of DLT 60~90 degrees in the same side with the tracheal lumen | Procedure or surgery | the DLT bending to the right |
| the DLT bending to the leftAlso: different bending mode of DLTbending the bronchial lumen of DLT 60~90 degree opposed to the tracheal lumen | Procedure or surgery | the DLT bending to the left |
Primary outcome
Main outcome measure is the successful rate of the first intubation compared with the two bending modes of DLT
Time frame: 12 month
6 secondary outcomes
the time needed to insert the DLT during the period of intubation
Time frame: 12 months
mean blood pressure (MAP) before intubation, and after intubation 1, 3,and 5 min
Time frame: 12 months
the incidence of hypoxemia during the period of intubation
Time frame: 12 months
the heart rate (HR) before intubation, and after intubation 1, 3,and 5 min
Time frame: 12 months
the incidence of sore throat after extubation
Time frame: 12 months
the incidence of hoarseness after extubation
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 8 Sep 2014.
- Derived from this study: PubMed 25206313Hsu HT, Chou SH, Chou CY, Tseng KY, Kuo YW, Chen MC, Cheng KI. A modified technique to improve the outcome of intubation with a left-sided double-lumen endobronchial tube. BMC Anesthesiol. 2014 Aug 18;14:72. doi: 10.1186/1471-2253-14-72. eCollection 2014.
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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 the DLT bending to the right and the DLT bending to the left 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 8 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 8 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 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 compared with the two bending modes of DLT (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 NCT01605591, 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 8 Sep 2014.