Mediastinal TumorsNCT02220231
Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation
A study testing capnothorax in people with Mediastinal Tumors, run by Yonsei University.
Trial summary
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Mediastinal Tumors
- What is being tested?
- capnothorax
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Mar 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 20 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- Thoracic surgical procedure (video-assisted thoracoscopic extended thymectomy )
Who cannot join
- Severe functional liver or kidney disease
- Diagnosed HF ( NYHA class >3)
- Arrhythmia or received treatment with antiarrhythmic drug .
- Exceed BMI > 30 kg/ m2
- COPD
- Pathologic esophageal lesion (esophageal stricture or varix )
- Pregnancy
About this study
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography.
Read the detailed description
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography
- Conditions
- Mediastinal Tumors
- Being tested
- capnothorax
- Keywords
- mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capnothoraxProcedure or surgery
Also called VATET, capnothorax, TEE
After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.
| Study group | Role | What they receive |
|---|---|---|
| capnothorax group | Experimental | After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy. Receives: Procedure: capnothorax |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of the echocardiographic indices
pulmonary blood flow = PVA(cross sectional area of LUPV) x VTI(velocity time integral) x HR , Fractional area change = [(LVAd-LVAs)/LVAd] × 100 Ejection fraction = [(LVEDV(LV end-diastolic volume) -LVESV(LV end-systolic volume)/LVEDV] × 100
Measured: four time points during the operation. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
Secondary outcomes (1)
The changes of the oxygenation and respiratory dynamic parameters
shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2) CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005
Measured: four time points during the operation, an expected average of 3 hours. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal TumorsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220231
- Sponsor's protocol ID
- 4-2014-0492
- Status last verified
- Apr 2015
- First submitted
- 6 Aug 2014
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation
- ClinicalTrials.gov ID
- NCT02220231
- Acronym / sponsor ID
- 4-2014-0492
- Conditions
- Mediastinal Tumors
- Keywords
- mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Aug 2014 (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.
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography.
Detailed description
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capnothorax group | Experimental | Procedure: capnothoraxAfter patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 20 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- Thoracic surgical procedure (video-assisted thoracoscopic extended thymectomy )
Key exclusion criteria (7 listed)
- Severe functional liver or kidney disease
- Diagnosed HF ( NYHA class >3)
- Arrhythmia or received treatment with antiarrhythmic drug .
- Exceed BMI > 30 kg/ m2
- COPD
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 |
|---|---|---|
| capnothoraxAlso: VATET, capnothorax, TEEAfter patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy. | Procedure or surgery | capnothorax group |
Primary outcome
The changes of the echocardiographic indices
Time frame: four time points during the operation. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
pulmonary blood flow = PVA(cross sectional area of LUPV) x VTI(velocity time integral) x HR , Fractional area change = [(LVAd-LVAs)/LVAd] × 100 Ejection fraction = [(LVEDV(LV end-diastolic volume) -LVESV(LV end-systolic volume)/LVEDV] × 100
1 secondary outcome
The changes of the oxygenation and respiratory dynamic parameters
Time frame: four time points during the operation, an expected average of 3 hours. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
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 17 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing capnothorax in people with Mediastinal Tumors, run by Yonsei University.
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 17 Apr 2015. 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?
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?
The changes of the echocardiographic indices (time frame: four time points during the operation. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation). 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 17 Apr 2015.