UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035122
Receipt No. R000040032
Official scientific title of the study 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Investigation of Postoperative Pulmonary Complication Risk Factors for Patients with Respiratory Dysfunction Subjected to Surgery
Title of the study (Brief title) 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 Yumi Obata
Organization St Marianna University School of Mddicine
Division name Anesthesiology
Address Sugao 2-16-1 Miyamae Kawasaki
TEL 044-977-8111
Email y2obata@marianna-u.ac.jp

Public contact
Name of contact person Yumi Obata
Organization St Marianna University School of Mddicine
Division name Anesthesiology
Address Sugao 2-16-1 Miyamae Kawasaki
TEL 044-977-8111
Homepage URL
Email y2obata@marianna-u.ac.jp

Sponsor
Institute St Marianna University School of Mddicine
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 10 Month 10 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040032

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.