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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037442
Receipt No. 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

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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 Obsterics 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
Email 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
Email funapon1116@gmail.com

Sponsor
Institute Division of Anesthesiology and Critical Care Medicin, Tottori University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042678

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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