Videoassisted Thoracoscopic Surgery,One-lung VentilationNCT03802968
The Application of Lung Ultrasound Combine With Diaphragm Ultrasound During Thoracic Surgery
An observational study of Videoassisted Thoracoscopic Surgery,One-lung Ventilation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Perioperative lung-protective strategies had been advocated in one-lung ventilation but normal respiratory functions were yet impacted during videoassisted thoracoscopic(VATS) surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Videoassisted Thoracoscopic Surgery,One-lung Ventilation
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2019to May 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective thoracoscopic surgery of OLV and over 18 years of age were included in the present study if they screened for the inclusion criteria. Patients were excluded if there were noncooperate from schizophrenia or delirium, a body mass index(BMI) higher than 40 kg/m2, a history of respiratory infection, chronic obstructive pulmonary disease(COPD), Chronic Heart Disease(CHD). Those received brachial plexus nerve block or general anesthesia within 2 weeks before surgery were also excluded. Former thoracic procedures (e.g.,thoracotomy, thoracoscopy or thoracic drain) were either criterions for exclusion.
Who may be able to join
- scheduled for elective thoracoscopic surgery of OLV, over 18 years of age
Who cannot join
- noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, a history of respiratory infection, a history of chronic obstructive pulmonary disease(COPD), a history of Chronic Heart Disease(CHD), received brachial plexus nerve block or general anesthesia within 2 weeks before surgery , received former thoracic procedures (e.g.,thoracotomy, thoracoscopy or thoracic drain)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, 13757118632 ext. 13252017900, zryanmin@zju.edu.cn
Chen Xie, 13252017900 ext. 13252017900, 1228617258@qq.com
About this study
Official title: The Perioperative Application of Lung Ultrasound Combine With Diaphragm Ultrasound In One-lung Ventilation During Thoracic Surgery
Perioperative lung-protective strategies had been advocated in one-lung ventilation but normal respiratory functions were yet impacted during videoassisted thoracoscopic(VATS) surgery. The primary aim of this study was to investigate respiratory complications after OLVby using bedside lung ultrasonography combine with diaphragmatic ultrasonography.
Read the detailed description
Perioperative lung-protective strategies had been advocated in One-lung Ventilation(OLV) of videoassisted thoracoscopic(VATS) surgery but normal respiratory functions were yet impacted during general anesthesia, mechanical ventilation, loss of respiratory muscle tone and intrathoracic surgery. Lung ultrasonography has been confirmed to be a available tool for rapid confirming atelectasis, pleural effusion , pneumonia and pneumothorax. Diaphragmatic excursion were well correlated with vital capacity by lung function testing and diaphragmatic ultrasound imaging was demonstrated accurately to identify atrophy and impaired contractility or motion of the diaphragm.The primary aim of this present study was to investigate respiratory complications after OLV in the postoperative period by using bedside lung ultrasonography.The secondary aim was to evaluate the variation of lung ventilation during thoracoscopic surgery through lung ultrasonography combine with diaphragm ultrasound and assess the accuracy of ultrasound to confirm proper endobronchial intubation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of respiratory complications after one-lung ventiltion(OLV) in the postoperative period by using bedside lung ultrasonography
Measured: 15 minutes after tracheal extubation
Secondary outcomes (1)
The variation of lung ventilation during thoracoscopic surgery through lung ultrasound combined with diaphragm ultrasound
Measured: before induction, 5 minutes after intubation, 5 minutes after surgery,15 minutes after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start10 Jan 2019
- Primary completionMar 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Videoassisted Thoracoscopic Surgery,One-lung VentilationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xuzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Min Yan, Doctor, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802968
- Sponsor's protocol ID
- 2018-185
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2019
- Last updated
- 20 Feb 2019
- 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 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Application of Lung Ultrasound Combine With Diaphragm Ultrasound In One-lung Ventilation During Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03802968
- Acronym / sponsor ID
- 2018-185
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Xuzhou Medical University
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 14 Jan 2019 (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.
Perioperative lung-protective strategies had been advocated in one-lung ventilation but normal respiratory functions were yet impacted during videoassisted thoracoscopic(VATS) surgery. The primary aim of this study was to investigate respiratory complications after OLVby using bedside lung ultrasonography combine with diaphragmatic ultrasonography.
Detailed description
Perioperative lung-protective strategies had been advocated in One-lung Ventilation(OLV) of videoassisted thoracoscopic(VATS) surgery but normal respiratory functions were yet impacted during general anesthesia, mechanical ventilation, loss of respiratory muscle tone and intrathoracic surgery. Lung ultrasonography has been confirmed to be a available tool for rapid confirming atelectasis, pleural effusion , pneumonia and pneumothorax. Diaphragmatic excursion were well correlated with vital capacity by lung function testing and diaphragmatic ultrasound imaging was demonstrated accurately to identify atrophy and impaired contractility or motion of the diaphragm.The primary aim of this present study was to investigate respiratory complications after OLV in the postoperative period by using bedside lung ultrasonography.The secondary aim was to evaluate the variation of lung ventilation during thoracoscopic surgery through lung ultrasonography combine with diaphragm ultrasound and assess the accuracy of ultrasound to confirm proper endobronchial intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective thoracoscopic surgery of OLV and over 18 years of age were included in the present study if they screened for the inclusion criteria. Patients were excluded if there were noncooperate from schizophrenia or delirium, a body mass index(BMI) higher than 40 kg/m2, a history of respiratory infection, chronic obstructive pulmonary disease(COPD), Chronic Heart Disease(CHD). Those received brachial plexus nerve block or general anesthesia within 2 weeks before surgery were also excluded. Former thoracic procedures (e.g.,thoracotomy, thoracoscopy or thoracic drain) were either criterions for exclusion.
Key inclusion criteria (1 listed)
- scheduled for elective thoracoscopic surgery of OLV, over 18 years of age
Key exclusion criteria (1 listed)
- noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, a history of respiratory infection, a history of chronic obstructive pulmonary disease(COPD), a history of Chronic Heart Disease(CHD), received brachial plexus nerve block or general anesthesia within 2 weeks before surgery , received former thoracic procedures (e.g.,thoracotomy, thoracoscopy or thoracic drain)
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
Rate of respiratory complications after one-lung ventiltion(OLV) in the postoperative period by using bedside lung ultrasonography
Time frame: 15 minutes after tracheal extubation
1 secondary outcome
The variation of lung ventilation during thoracoscopic surgery through lung ultrasound combined with diaphragm ultrasound
Time frame: before induction, 5 minutes after intubation, 5 minutes after surgery,15 minutes after tracheal extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- 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.
Min Yan, Doctor study chair
Zhejiang University
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 Videoassisted Thoracoscopic Surgery,One-lung Ventilation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 1 inclusion and 1 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 20 Feb 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Xie, Master (13252017900 ext. 13252017900, 1228617258@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of respiratory complications after one-lung ventiltion(OLV) in the postoperative period by using bedside lung ultrasonography (time frame: 15 minutes after tracheal extubation). 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 20 Feb 2019.