UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037442 |
|---|---|
| Receipt number | R000042678 |
| Scientific Title | Investigation on exhaled nitrogen chemicals in patients undergoing abdominal surgery |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2019/07/21 21:47:41 |
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Basic information
Public title
Investigation on exhaled nitrogen chemicals in patients undergoing abdominal surgery
Acronym
Investigation on exhaled nitrogen chemicals in patients undergoing abdominal surgery
Scientific Title
Investigation on exhaled nitrogen chemicals in patients undergoing abdominal surgery
Scientific Title:Acronym
Investigation on exhaled nitrogen chemicals in patients undergoing abdominal surgery
Region
| Japan |
Condition
Condition
abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Vascular surgery |
| Endocrine surgery | Obstetrics and Gynecology | Urology |
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In patients undergoing abdominal surgery under general anesthesia, to measure the concentration of exhaled nitrogen chemicals (NO, NO2, HONO) at the perioperative period and to evaluate the effect of surgery. Also, to evaluate blood ROS, blood cytokines, hematological examination, blood biochemistry examination, arterial blood and blood gas analysis examination, lung function, anesthesia method, the relation with the operation contents.
Basic objectives2
Others
Basic objectives -Others
epidemiology research
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change in exhaled NO, NO2, HONO concentration during perioperative period
Key secondary outcomes
1) relevance of exhaled NO, NO2, HONO and blood ROS during perioperative period
2) relevance of exhaled NO, NO2, HONO and blood cytokines during perioperative period
3) relevance of exhaled NO, NO2, HONO and blood biomarkers during perioperative period
4) relevance of exhaled NO, NO2, HONO and hematological examination, blood biochemical examination, arterial blood gas analysis examination during perioperative period
5) relevance of exhaled NO, NO2, HONO and pulmonary function during perioperative period
6) Whether the exhaled NO, NO2 and HONO concentrations are related to the anesthesia method during perioperative period
7) Whether the exhaled NO, NO 2 and HONO concentrations in the perioperative period are related to the operation conten
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
1) patients over 40 years at the time of obtaining informed consent
2) of regular operation patients who undergo abdominal surgery under general anesthesia, those who are scheduled to be treated in the postoperative intensive care unit (ICU)
3) patients who have 3 hours or more of scheduled operation time
4) patients who have obtained consent from the person
Key exclusion criteria
1) patients undergoing surgery requiring general anesthesia within 3 months prior to obtaining informed consent
2) patients with acute respiratory failure (pneumonia, acute respiratory distress syndrome etc.)
3) patients who undergo emergency surgery
4) patients with sepsis or septic shock
5) Patients with progressive neuromuscular disease
6) Patients undergoing thoracic surgery
7) highly obese patients (BMI 35 kg / m2 or more)
8) women who are pregnant or have pregnancy possibility
9) patients who received study drugs or investigational drugs within 3 months prior to obtaining informed consent
10) patinets whom research investigator has determined to be inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Funaki |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
funapon1116@gmail.com
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Funaki |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
Homepage URL
funapon1116@gmail.com
Sponsor or person
Institute
Division of Anesthesiology and Critical Care Medicin, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Division of Anesthesiology and Critical Care Medicin, Tottori University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University School of Medicine Ethics Committee
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
Tel
0859-38-7108
me-rinshoukenkyu@adm.tottori-u.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
| 2019 | Year | 07 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In patients undergoing abdominal surgery under general anesthesia, to measure the concentration of exhaled nitrogen chemicals (NO, NO2, HONO) at the perioperative period and to evaluate the effect of surgery. Also, to evaluate blood ROS, blood cytokines, hematological examination, blood biochemistry examination, arterial blood and blood gas analysis examination, lung function, anesthesia method, the relation with the operation contents.
Management information
Registered date
| 2019 | Year | 07 | Month | 21 | Day |
Last modified on
| 2019 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042678
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