Minimally Invasive Cardiac SurgeryNCT03505242
Application of Bronchial Blocker in Minimally Invasive Cardiac Surgery
A study testing bronchial blocker for BB group and double lumen tube for DLT group in people with Minimally Invasive Cardiac Surgery, run by Shanghai Zhongshan Hospital.
Trial summary
Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Minimally Invasive Cardiac Surgery
- What is being tested?
- bronchial blocker for BB group and double lumen tube for DLT group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 May 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II-III
- BMI 18-31
- elective minimally invasive cardiac surgery by right thoracotomy
Who cannot join
- asthma
- COPD
- previous lung surgery
- previous cardiac surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bronchial Blocker in Blocking the Right Middle Lower Lobe Versus Double-Lumen Endotracheal Tube for One-Lung Ventilation in Minimally Invasive Cardiac Surgery
Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. The current study was designed to compare the impact of these two different methods on oxygenation, degree of pulmonary collapse and postoperative complications.
- Conditions
- Minimally Invasive Cardiac Surgery
- Being tested
- bronchial blocker for BB group, double lumen tube for DLT group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial blocker for BB groupDevice
Using bronchial blocker to block right middle lower lobe during surgery.
double lumen tube for DLT groupDevice
Using double lumen tube to achieve single lung ventilation during surgery.
| Study group | Role | What they receive |
|---|---|---|
| BB | Experimental | Not described Receives: Device: bronchial blocker for BB group |
| DLT | Experimental | Not described Receives: Device: double lumen tube for DLT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation
record SpO2 and PaO2 during selective ventilation
Measured: intraoperative
Secondary outcomes (1)
degree of pulmonary collapse
surgeon score the degree of pulmonary collapse (1 for no pulmonary collapse and 5 for excellent pulmonary collapse)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505242
- Sponsor's protocol ID
- ABMICS
- Status last verified
- Apr 2018
- First submitted
- 30 Aug 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Blocker in Blocking the Right Middle Lower Lobe Versus Double-Lumen Endotracheal Tube for One-Lung Ventilation in Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03505242
- Acronym / sponsor ID
- ABMICS
- Conditions
- Minimally Invasive Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 23 Apr 2018 (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.
Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. The current study was designed to compare the impact of these two different methods on oxygenation, degree of pulmonary collapse and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BB | Experimental | Device: bronchial blocker for BB group |
| DLT | Experimental | Device: double lumen tube for DLT group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA II-III
- BMI 18-31
- elective minimally invasive cardiac surgery by right thoracotomy
Key exclusion criteria (4 listed)
- asthma
- COPD
- previous lung surgery
- previous cardiac surgery
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 |
|---|---|---|
| bronchial blocker for BB groupUsing bronchial blocker to block right middle lower lobe during surgery. | Device | BB |
| double lumen tube for DLT groupUsing double lumen tube to achieve single lung ventilation during surgery. | Device | DLT |
Primary outcome
oxygenation
Time frame: intraoperative
record SpO2 and PaO2 during selective ventilation
1 secondary outcome
degree of pulmonary collapse
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 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.
Questions about this trial
What is this clinical trial studying?
A study testing bronchial blocker for BB group and double lumen tube for DLT group in people with Minimally Invasive Cardiac Surgery, run by Shanghai Zhongshan 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 4 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 23 Apr 2018. 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.
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 Kefang Guo (+8613817706936, guo.kefang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation (time frame: intraoperative). 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 23 Apr 2018.