UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035122 |
|---|---|
| Receipt number | R000040032 |
| Scientific Title | Investigation of Postoperative Pulmonary Complication Risk Factors for Patients with Respiratory Dysfunction Subjected to Surgery |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2018/12/03 20:27:09 |
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Basic information
Public title
Investigation of Postoperative Pulmonary Complication Risk Factors for Patients with Respiratory Dysfunction Subjected to Surgery
Acronym
Investigation of Postoperative Pulmonary Complication Risk Factors for Patients with Respiratory Dysfunction Subjected to Surgery
Scientific Title
Investigation of Postoperative Pulmonary Complication Risk Factors for Patients with Respiratory Dysfunction Subjected to Surgery
Scientific Title:Acronym
Investigation of Postoperative Pulmonary Complication Risk Factors for Patients with Respiratory Dysfunction Subjected to Surgery
Region
| Japan |
Condition
Condition
Obstructive ventilatory disorder, mixed ventilatory disorder
Stomach cancer
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with preoperative respiratory depression are considered to be at high risk of postoperative pulmonary complications, especially with the use of muscle relaxant drugs due to general anesthesia or artificial respiration. For patients with severe respiratory depression, a surgical operation / anesthesia method to avoid general anesthesia is selected, but depending on the results of preoperative respiratory function test, it is clear about judgment whether general anesthesia is possible There is no standard.
Basic objectives2
Others
Basic objectives -Others
This time, in the respiratory depressed patient who underwent the surgical operation in the past 10 years, the patient background, the operation type, the anesthesia method, and the postoperative pulmonary complication were examined retrospectively, and the judgment of the general anesthesia availability by the preoperative respiratory function test result Will it be possible to investigate? We also examine risk factors for postoperative pulmonary complications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
As a preoperative factor, a surgical expression (laparotomy, laparoscope), surgical procedure (laparotomy, laparoscopic surgery) as a surgical factor, respiratory function test (% VC, vital capacity, 1 second amount, 1 second rate), past history, smoking history, About surgical time, anesthesia time, anesthesia method Use Mann - Whitney test, chi - square test, logistic regression analysis to investigate the possibility of general anesthesia and the risk factor of postoperative pulmonary complications.
Key secondary outcomes
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
September 1, 2008 - August 31, Heisei 30
Patients with respiratory depression who underwent surgery for the past 10 years
Key exclusion criteria
Emergency case
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumi Obata |
Organization
St Marianna University School of Mddicine
Division name
Anesthesiology
Zip code
Address
Sugao 2-16-1 Miyamae Kawasaki
TEL
044-977-8111
y2obata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Obata |
Organization
St Marianna University School of Mddicine
Division name
Anesthesiology
Zip code
Address
Sugao 2-16-1 Miyamae Kawasaki
TEL
044-977-8111
Homepage URL
y2obata@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University School of Mddicine
Institute
Department
Personal name
Funding Source
Organization
St Marianna University School of Mddicine
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
YES
Study ID_1
4178
Org. issuing International ID_1
4178
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 | 12 | Month | 03 | 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
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyzed from 2015 to 2018
Management information
Registered date
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040032
