Complication of Ventilation TherapyPhase 4NCT02729610
Bronchial Blocker for One-lung Ventilation in Cardiac Surgery
A Phase 4 study testing double-lumen endotracheal tube (DLT group) and endobronchial blocker (BB group) in people with Complication of Ventilation Therapy and Intubation Complication, run by Xijing Hospital.
Trial summary
To investigate if bronchial blocker is more suitable for one-lung ventilation during thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the double-lumen endobronchial tube. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complication of Ventilation Therapy, Intubation Complication, Postoperative; Dysfunction Following Cardiac Surgery
- What is being tested?
- double-lumen endotracheal tube (DLT group) and endobronchial blocker (BB group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2016
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New York Heart Association (NYHA)I-III level.
- scheduled for thoracoscope assisted mitral valve surgery under surgery
- provide with informed consent.
Who cannot join
- emergency surgery.
- preoperative pulmonary diseases, such as chronic obstructive pulmonary disease, atelectasis.
- preoperative voice hoarse or sore throat.
- involved in other clinical trials within 3 months .
- Cannot cooperate with language understanding disorders or psychological problems.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Bronchial Blocker Versus Double Lumen Tube for One-lung Ventilation During Thoracoscope Assisted Mitral Valve Replacement
To investigate if bronchial blocker is more suitable for one-lung ventilation during thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the double-lumen endobronchial tube.
Read the detailed description
Postoperative hoarseness, sore throat, and vocal cord injuries are common complications after general anesthesia. The incidence of postoperative hoarseness is as frequent as 50% after short-term tracheal intubation. In the past, several risk factors for postoperative hoarseness and laryngeal injury have been identified, including demographic factors, quality of tracheal intubation and technical factors such as endotracheal tube size. One-lung ventilation during thoracotomy can be achieved via two basic techniques: (1) use of a double-lumen endotracheal tube (DLT) consisting of an endotracheal and an endobronchial lumen allowing independent single-lung ventilation ; or (2) use of an endobronchial blocker such as the Arndt blocker, which allows lung collapse distal to the occlusion. It has been recently demonstrated that DLT and endobronchial blocker are similar in their efficacy to achieve lung isolation for elective thoracic surgery. No data are available yet about the influence of the chosen technique on postoperative hoarseness, vocal cord injuries, sore throat, and bronchial injuries. Published data of Stout et al. imply that the incidence of postoperative hoarseness and vocal cord injury might be directly correlated with size of the used endotracheal tube. During thoracoscope assisted mitral valve replacement cardiac surgery, excellent lung isolated was not required. One-lung ventilation with the other lung collapsed is used to achieve a better exposure and assist the surgery. During the cardiac surgery under cardiopulmonary bypass, heparinization will lead to uncontrolled hemorrhage if there is endotracheal tube insertion associated injury. In addition, DLTs need to be exchanged for a single-lumen tube before the patient transferring to cardiac care unit for postoperative ventilatory support. This may result in second time injury. Investigators hypothesized that using a bronchial blocker to achieve one-lung ventilation may result in a lower incidence of clinically relevant laryngeal and bronchial morbidity after thoracoscope assisted mitral valve replacement cardiac surgery compared with a control group intubated with a DLT.
- Conditions
- Complication of Ventilation Therapy, Intubation Complication, Postoperative; Dysfunction Following Cardiac Surgery
- Being tested
- double-lumen endotracheal tube (DLT group), endobronchial blocker (BB group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double-lumen endotracheal tube (DLT group)Device
In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation
endobronchial blocker (BB group)Device
In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| DLT group | Active comparator | In this arm, patient will be intubated with a double lumen endotracheal tube Receives: Device: double-lumen endotracheal tube (DLT group) |
| BB group | Experimental | In this arm, patient will be intubated with an endobronchial blocker Receives: Device: endobronchial blocker (BB group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinically relevant laryngeal and bronchial morbidity
incidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications
Measured: perioperative period
Secondary outcomes (6)
Heart Rate
Heart rate in BPM will be recorded at right before intubation (T1), at intubation (T2), and at three minutes after intubation (T3).
Measured: perioperative period
Central Venous Pressure
Central venous pressure in cmH2O will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).
Measured: perioperative period
Blood Pressure
Systolic blood pressure, diastolic blood pressure and mean arterial pressure all in mmHg will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).
Measured: perioperative period
the Duration of Ventilation
It is the duration of ventilation, prolonged ventilation is defined as patients remaining on the ventilator for more than 48 hours
Measured: The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours.
Length of Postoperative Hospital Stay
Recorded the time of postoperative hospital stay in days.
Measured: Length of postoperative hospital stay in days will be recorded which is defined as the time from surgery to hospital discharge, an expected average of 10 days
Length of CCU Stay
It is the length of stay in cardiac ICU
Measured: Length of CCU stay in hours will be recorded which is defined as the time stay in the cardiac intensive care unit, an expected average of 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Complication of Ventilation TherapyStudies of the same condition, open and under way.
- More trials run by Xijing 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HailongDong, Xijing Hospital
- Investigators
- Hailong Dong, MD & PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729610
- Sponsor's protocol ID
- KY20153001-1
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yoo JY, Kim DH, Choi H, Kim K, Chae YJ, Park SY. Disconnection technique with a bronchial blocker for improving lung deflation: a comparison with a double-lumen tube and bronchial blocker without disconnection. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):904-7. doi: 10.1053/j.jvca.2013.07.019. Epub 2013 Nov 11.
PubMed 24231197Kuo AS, Philip JH, Edrich T. Airway ventilation pressures during bronchoscopy, bronchial blocker, and double-lumen endotracheal tube use: an in vitro study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):873-9. doi: 10.1053/j.jvca.2013.03.023. Epub 2013 Sep 7.
PubMed 24021918Guo C, Ma C, Yu L. [Comparative of coopdech bronchial blocker and double-lumen tube on one lung ventilation in children]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1651-3. Chinese.
PubMed 25152290Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005.
PubMed 23101777Ruetzler K, Grubhofer G, Schmid W, Papp D, Nabecker S, Hutschala D, Lang G, Hager H. Randomized clinical trial comparing double-lumen tube and EZ-Blocker for single-lung ventilation. Br J Anaesth. 2011 Jun;106(6):896-902. doi: 10.1093/bja/aer086. Epub 2011 Apr 14.
PubMed 21493621Lei Q, Zeng QS, Zhang XS, Xie B, Luo ZC, Guo HM, Chen JM, Zhuang J. Superior vena cava drainage during thoracoscopic cardiac surgery: bilateral internal jugular vein sheaths versus one percutaneous superior vena cava cannula. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):914-8. doi: 10.1053/j.jvca.2013.05.043. Epub 2013 Oct 16.
PubMed 24139456
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bronchial Blocker Versus Double Lumen Tube for One-lung Ventilation During Thoracoscope Assisted Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT02729610
- Acronym / sponsor ID
- KY20153001-1
- Conditions
- Complication of Ventilation Therapy, Intubation Complication, Postoperative; Dysfunction Following Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 6 Apr 2016 (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.
To investigate if bronchial blocker is more suitable for one-lung ventilation during thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the double-lumen endobronchial tube.
Detailed description
Postoperative hoarseness, sore throat, and vocal cord injuries are common complications after general anesthesia. The incidence of postoperative hoarseness is as frequent as 50% after short-term tracheal intubation. In the past, several risk factors for postoperative hoarseness and laryngeal injury have been identified, including demographic factors, quality of tracheal intubation and technical factors such as endotracheal tube size. One-lung ventilation during thoracotomy can be achieved via two basic techniques: (1) use of a double-lumen endotracheal tube (DLT) consisting of an endotracheal and an endobronchial lumen allowing independent single-lung ventilation ; or (2) use of an endobronchial blocker such as the Arndt blocker, which allows lung collapse distal to the occlusion. It has been recently demonstrated that DLT and endobronchial blocker are similar in their efficacy to achieve lung isolation for elective thoracic surgery. No data are available yet about the influence of the chosen technique on postoperative hoarseness, vocal cord injuries, sore throat, and bronchial injuries. Published data of Stout et al. imply that the incidence of postoperative hoarseness and vocal cord injury might be directly correlated with size of the used endotracheal tube. During thoracoscope assisted mitral valve replacement cardiac surgery, excellent lung isolated was not required. One-lung ventilation with the other lung collapsed is used to achieve a better exposure and assist the surgery. During the cardiac surgery under cardiopulmonary bypass, heparinization will lead to uncontrolled hemorrhage if there is endotracheal tube insertion associated injury. In addition, DLTs need to be exchanged for a single-lumen tube before the patient transferring to cardiac care unit for postoperative ventilatory support. This may result in second time injury. Investigators hypothesized that using a bronchial blocker to achieve one-lung ventilation may result in a lower incidence of clinically relevant laryngeal and bronchial morbidity after thoracoscope assisted mitral valve replacement cardiac surgery compared with a control group intubated with a DLT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLT group | Active comparator | Device: double-lumen endotracheal tube (DLT group)In this arm, patient will be intubated with a double lumen endotracheal tube |
| BB group | Experimental | Device: endobronchial blocker (BB group)In this arm, patient will be intubated with an endobronchial blocker |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New York Heart Association (NYHA)I-III level.
- scheduled for thoracoscope assisted mitral valve surgery under surgery
- provide with informed consent.
Key exclusion criteria (5 listed)
- emergency surgery.
- preoperative pulmonary diseases, such as chronic obstructive pulmonary disease, atelectasis.
- preoperative voice hoarse or sore throat.
- involved in other clinical trials within 3 months .
- Cannot cooperate with language understanding disorders or psychological problems.
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 |
|---|---|---|
| double-lumen endotracheal tube (DLT group)In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation | Device | DLT group |
| endobronchial blocker (BB group)In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation | Device | BB group |
Primary outcome
clinically relevant laryngeal and bronchial morbidity
Time frame: perioperative period
incidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications
6 secondary outcomes
Heart Rate
Time frame: perioperative period
Central Venous Pressure
Time frame: perioperative period
Blood Pressure
Time frame: perioperative period
the Duration of Ventilation
Time frame: The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours.
Length of Postoperative Hospital Stay
Time frame: Length of postoperative hospital stay in days will be recorded which is defined as the time from surgery to hospital discharge, an expected average of 10 days
Length of CCU Stay
Time frame: Length of CCU stay in hours will be recorded which is defined as the time stay in the cardiac intensive care unit, an expected average of 3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Background: PubMed 24231197Yoo JY, Kim DH, Choi H, Kim K, Chae YJ, Park SY. Disconnection technique with a bronchial blocker for improving lung deflation: a comparison with a double-lumen tube and bronchial blocker without disconnection. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):904-7. doi: 10.1053/j.jvca.2013.07.019. Epub 2013 Nov 11.
- Background: PubMed 24021918Kuo AS, Philip JH, Edrich T. Airway ventilation pressures during bronchoscopy, bronchial blocker, and double-lumen endotracheal tube use: an in vitro study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):873-9. doi: 10.1053/j.jvca.2013.03.023. Epub 2013 Sep 7.
- Background: PubMed 25152290Guo C, Ma C, Yu L. [Comparative of coopdech bronchial blocker and double-lumen tube on one lung ventilation in children]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1651-3. Chinese.
- Background: PubMed 23101777Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005.
- Background: PubMed 21493621Ruetzler K, Grubhofer G, Schmid W, Papp D, Nabecker S, Hutschala D, Lang G, Hager H. Randomized clinical trial comparing double-lumen tube and EZ-Blocker for single-lung ventilation. Br J Anaesth. 2011 Jun;106(6):896-902. doi: 10.1093/bja/aer086. Epub 2011 Apr 14.
- Background: PubMed 24139456Lei Q, Zeng QS, Zhang XS, Xie B, Luo ZC, Guo HM, Chen JM, Zhuang J. Superior vena cava drainage during thoracoscopic cardiac surgery: bilateral internal jugular vein sheaths versus one percutaneous superior vena cava cannula. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):914-8. doi: 10.1053/j.jvca.2013.05.043. Epub 2013 Oct 16.
- Individual participant dataSharing planned: Undecided
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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.
Hailong Dong, MD & PhD principal investigator
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing double-lumen endotracheal tube (DLT group) and endobronchial blocker (BB group) in people with Complication of Ventilation Therapy and Intubation Complication, run by Xijing Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hailong Dong, MD & PhD (86-29-84775337, hldong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinically relevant laryngeal and bronchial morbidity (time frame: perioperative period). 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 NCT02729610, which also lists 6 linked publications.
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 6 Apr 2016.