UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053288 |
|---|---|
| Receipt number | R000060767 |
| Scientific Title | A prospective observational study to evaluate appropriate extubation time of postoperative patients using chest X-ray Dynamic Digital Radiography (DDR). |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2025/01/11 22:54:02 |
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Basic information
Public title
A prospective observational study to evaluate appropriate extubation time of postoperative patients using chest X-ray Dynamic Digital Radiography (DDR).
Acronym
A prospective observational study to evaluate appropriate postoperative extubation time using Dynamic Digital Radiography (DDR).
Scientific Title
A prospective observational study to evaluate appropriate extubation time of postoperative patients using chest X-ray Dynamic Digital Radiography (DDR).
Scientific Title:Acronym
A prospective observational study to evaluate appropriate postoperative extubation time using Dynamic Digital Radiography (DDR).
Region
| Japan |
Condition
Condition
postoperative patients on mechanical ventilation
Classification by specialty
| Anesthesiology | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among patients who are weaned from mechanical ventilation after surgery, those who require positive pressure ventilation again before leaving ICU are being compared with those who do not. Before and after surgery or before weaning from ventilator, digital dynamic radiography is performed, and those results are compared between the groups. The purpose of this study is to examine the optimal timing of extubation, and ultimately to reduce the reintubation rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistical analysis will be performed to compare the changes in effective ventilation area and ventilation-perfusion mismatch before and after surgery between the group that only underwent non-invasive oxygen therapy without positive pressure after extubation until ICU discharge (S group) and the group that required re-intubation or NPPV (F group). However, NPPV which was preventively used right after the extubation will not be considered as a failure of extubation The final evaluation period is when patients are discharged from ICU.
Key secondary outcomes
Weight gain rate from before surgery to ICU admission, comparison of pre-operative findings with digital dynamic radiography at each phase, rapid shallow breathing index: RSBI, APACHE-II score, static lung compliance just before extubation. Tidal volume, respiratory rate, and heart rate during spontaneous breathing are also being considered.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who require mechanical ventilation after surgery under general anesthesia
Key exclusion criteria
Patients with a history of breast cancer, patients who may be pregnant, and patients who refuse informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hidehisa |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Division of Surgical Center
Zip code
980-8575
Address
2-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
Homepage URL
hidehisa.saito.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
| 2024 | Year | 01 | Month | 12 | 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
| Delay expected |
Results Delay Reason
We have not obtained significant data yet.
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
| 2023 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The estimated increase in radiation exposure per procedure in this study is approximately 0.3 mSv, based on an average surface dose of 2.9 mGy and an effective dose conversion factor of 0.1 mSv/mGy. Assuming that the additional exposure from three times of examinations is approximately 1 mSv, this is approximately 1/5 of the effective dose of a typical chest CT scan (about 5 mSv). The risk of cancer or death is small. To minimize the risk of radiation exposure, study participants is limited to adults over 40 years old, and patients with a history of breast cancer and women who may be pregnant will be excluded.
Management information
Registered date
| 2024 | Year | 01 | Month | 07 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060767
