UMIN-CTR Clinical Trial

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

Obstructive ventilatory disorder, mixed ventilatory disorder
Stomach cancer
Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

y2obata@marianna-u.ac.jp

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

Email

y2obata@marianna-u.ac.jp

Institute

St Marianna University School of Mddicine

Institute

Department

Personal name

Organization

St Marianna University School of Mddicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2018

Year

12

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Analyzed from 2015 to 2018

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