UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031533 |
|---|---|
| Receipt number | R000035066 |
| Scientific Title | Evaluation of perioperative respiratory management after lung resection using displacement sensor |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2021/09/25 21:35:19 |
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Basic information
Public title
Evaluation of perioperative respiratory management after lung resection using displacement sensor
Acronym
Respiratory management after lung resection with displacement sensor
Scientific Title
Evaluation of perioperative respiratory management after lung resection using displacement sensor
Scientific Title:Acronym
Respiratory management after lung resection with displacement sensor
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) Verify the accuracy of thorax orintercostal muscle movement measurement by displacement sensor.
2)Visualize changes in respiratory state from accumulated information and aim at sharing information.
3) Analyze the analysis result and actual clinical information and verify whether prevention and early detection of postoperative pulmonary complications are possible
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between measured respiratory measurements and postoperative respiratory complications within 7 days after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
method
Measurement method: Install a displacement sensor with a pad similar to the electrocardiogram so as to cross obliquely across the 6th and 9th intercostal spaces on both sides. For the operative side, when overlapping with the post-operative drain insertion site, the deviation of one intercostal space is allowed as the setting range.
For the displacement sensor and the dedicated PC, it is transmitted by wire. Since it is installed at each place on both sides, data acquisition and management are performed with 2ch input / output.
Mainly on data acquisition on the bed, monitor is interrupted during walking and rehabilitation.
The wired lead part is connected via an adapter in order to facilitate attachment / detachment / connection of the connection with the PC. In case
Measurement period: From immediately after surgery to 5 days after surgery. If the condition is satisfied, the measurement may be terminated at an early stage.
Interventions/Control_2
Normal group: preoperative pulmonary function,% FEV 1,% VC not decreasing.
Low lung function group: Those which do not meet standards in the respiratory function test defined above. Or, it was pointed out in interpretation of interstitial pneumonia by radiation radiology in preoperative CT images.
Register for 30 cases in each group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.A non-small cell lung cancer patient who is scheduled to perform a pulmonary resection operation
2.Those who are not diagnosed with pulmonary emphysema/interstitial pneumonia due to preoperative examination and do not show decreased respiratory function.
3.The presence of interstitial pneumonia is confirmed on the image. Information that can be observed for more than 30 days after surgery, information such as patient background, perioperative factor, prognosis, presence or absence of acute exacerbation can be obtained or expected to be possible. Those that are expected to be able to acquire these information even in the case of death within 30 days.
4.For preclinical pulmonary function tests, those classified as 2 degree or more (%FEV1 <70%) by Gold classification are targeted. It does not matter whether or not internal or inhalation therapy for pulmonary emphysema is present. It is possible to observe 30 days or more postoperatively, and information such as patient background, perioperative factor, prognosis etc. can be acquired or expected to be possible. Those that are expected to be able to acquire these information even in the case of death within 30 days.
5.Agreement When aged 20 years or older
6.Patients who gave sufficient consultation on participation of this study and obtained consent
Key exclusion criteria
1)There is a history of allergy to the material
2)not attach sensor due to complications of skin diseases
3)difficult to self-decide due to dementia, disorientation of consciousness, etc.
4) Other cases that the investigator considered to be inappropriate as the subject of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kobayashi Masashi |
Organization
Tokyo Medical and Dental University
Division name
Thoracic Surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-0375
mkobthsr@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kobayashi Masashi |
Organization
Tokyo Medical and Dental University
Division name
Thoracic Surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-0375
Homepage URL
mkobthsr@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035066
