UMIN-CTR Clinical Trial

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