- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03802968
The Application of Lung Ultrasound Combine With Diaphragm Ultrasound During Thoracic Surgery
February 18, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Unknown
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 Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chen Xie, Master
- Phone Number: 13252017900 13252017900
- Email: 1228617258@qq.com
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- The Second Affiliated Hospital of Zhejiang University
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Contact:
- Chen Xie
- Phone Number: 13252017900 13252017900
- Email: 1228617258@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- scheduled for elective thoracoscopic surgery of OLV, over 18 years of age
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
15 minutes after tracheal extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
before induction, 5 minutes after intubation, 5 minutes after surgery,15 minutes after tracheal extubation
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accuracy of Lung ultrasound in confirming proper endobronchial intubation
Time Frame: 5 minutes after one- lung ventilation
|
5 minutes after one- lung ventilation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2019
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
May 1, 2019
Study Registration Dates
First Submitted
January 2, 2019
First Submitted That Met QC Criteria
January 10, 2019
First Posted (Actual)
January 14, 2019
Study Record Updates
Last Update Posted (Actual)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2018-185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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