Lung NeoplasmsNCT02123173
Hemodynamic Changes During One Lung Ventilation in Non-intubated Vedio-assisted Thoracoscopic Operations
An observational study of Lung Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management of many lung conditions such as pneumothorax , lung volume reduction, pulmonary metastasectomy, removal of lung nodules, segmentectomy and lobectomy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Lung Neoplasms
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Dec 2014
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled to receive video-assisted thoracoscopic (VATS) operations with one lung ventilation(OLV) Inclusion criteria: 1. age over 20 y/o, less than 70 y/o 2. scheduled to receive VATS operations with OLV Exclusion: 1. previous thoracic surgery 2. cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.) 3. pulmonary disease
Who may be able to join
- age over 20 y/o, less than 70 y/o
- scheduled to receive VATS operations with OLV
Who cannot join
- previous thoracic surgery
- cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.)
- pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Changes and Fluid Responsiveness During One Lung Ventilation: Comparison in Non-intubated and Intubated Vedio-assisted Thoracoscopic Operations
Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management of many lung conditions such as pneumothorax , lung volume reduction, pulmonary metastasectomy, removal of lung nodules, segmentectomy and lobectomy. However, the hemodynamic changes during one lung ventilation have not been fully investigated. The goals of this study are to compare the changes of hemodynamics (including blood pressure, heart rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic (VATS) operations.
Read the detailed description
Non-intubated vedio-assisted thoracoscopic (VATS) is proved safely performed as well as traditional intubated VATS. However, the differences of hemodynamic changes and fluid responsiveness during one lung ventilation(OLV) between these two groups were rarely reported. For complete lung collapse, spontaneous negative pressure respiration must be well maintained on non-intubated VATS. In comparison, positive pressure ventilation on dependent lung was applied during OLV in intubated VATS. This study planned to compared the changes of hemodynamics (including blood pressure, heart rate, cardiac output) during OLV between groups. As functional hemodynamic monitoring (FloTrac system) was mostly utilized with positive pressure ventilation, the applicability of FloTrac in non- intubated VATS was also testified. In this study, we also measure the fluid responsiveness by FloTrac system with rapid infusion (within 10 minutes) of 10 mL/kg crystalloid fluid. We planned to compare the changes on cardiac output and the fluid responsiveness during OLV between these two groups.
- Conditions
- Lung Neoplasms
- Keywords
- one lung ventilation,, cardiac output, fluid responsiveness
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-intubated | VATS, non-intubated | |
| intubated | VATS, intubated |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output after one lung ventilation
record the stroke volume and cardiac output during two lung ventilation till 15 minutes after one lung ventilation
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Jung Cheng, Principal investigator, department of anesthesiology, national taiwan university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123173
- Sponsor's protocol ID
- 201401037RINB
- Status last verified
- Dec 2014
- First submitted
- 21 Apr 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes and Fluid Responsiveness During One Lung Ventilation: Comparison in Non-intubated and Intubated Vedio-assisted Thoracoscopic Operations
- ClinicalTrials.gov ID
- NCT02123173
- Acronym / sponsor ID
- 201401037RINB
- Conditions
- Lung Neoplasms
- Keywords
- one lung ventilation,, cardiac output, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Apr 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.
Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management of many lung conditions such as pneumothorax , lung volume reduction, pulmonary metastasectomy, removal of lung nodules, segmentectomy and lobectomy. However, the hemodynamic changes during one lung ventilation have not been fully investigated. The goals of this study are to compare the changes of hemodynamics (including blood pressure, heart rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic (VATS) operations.
Detailed description
Non-intubated vedio-assisted thoracoscopic (VATS) is proved safely performed as well as traditional intubated VATS. However, the differences of hemodynamic changes and fluid responsiveness during one lung ventilation(OLV) between these two groups were rarely reported. For complete lung collapse, spontaneous negative pressure respiration must be well maintained on non-intubated VATS. In comparison, positive pressure ventilation on dependent lung was applied during OLV in intubated VATS. This study planned to compared the changes of hemodynamics (including blood pressure, heart rate, cardiac output) during OLV between groups. As functional hemodynamic monitoring (FloTrac system) was mostly utilized with positive pressure ventilation, the applicability of FloTrac in non- intubated VATS was also testified. In this study, we also measure the fluid responsiveness by FloTrac system with rapid infusion (within 10 minutes) of 10 mL/kg crystalloid fluid. We planned to compare the changes on cardiac output and the fluid responsiveness during OLV between these two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-intubated | – | –VATS, non-intubated |
| intubated | – | –VATS, intubated |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled to receive video-assisted thoracoscopic (VATS) operations with one lung ventilation(OLV) Inclusion criteria: 1. age over 20 y/o, less than 70 y/o 2. scheduled to receive VATS operations with OLV Exclusion: 1. previous thoracic surgery 2. cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.) 3. pulmonary disease
Key inclusion criteria (2 listed)
- age over 20 y/o, less than 70 y/o
- scheduled to receive VATS operations with OLV
Key exclusion criteria (3 listed)
- previous thoracic surgery
- cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.)
- pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac output after one lung ventilation
Time frame: 10-15 minutes
record the stroke volume and cardiac output during two lung ventilation till 15 minutes after one lung ventilation
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 4 Dec 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.
Ya-Jung Cheng principal investigator
department of anesthesiology, national taiwan university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by National Taiwan University 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 2 inclusion and 3 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 4 Dec 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?
cardiac output after one lung ventilation (time frame: 10-15 minutes). 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 4 Dec 2014.