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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031533
Receipt No. 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 2018/09/01

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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
Email 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
Email mkobthsr@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email

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
Anticipated trial start date
2018 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 01 Day
Last modified on
2018 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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