UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Acronym	Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Scientific Title	Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Scientific Title:Acronym	Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Region	Japan

Condition
Condition	Diseases for which surgery is indicated
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Pediatrics Oto-rhino-laryngology Orthopedics Urology Anesthesiology Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	With COVID19, preoperative respiratory function tests will not be performed. We will examine whether the respiratory function test, which has been performed as a preoperative test, is necessary for perioperative management and is useful for predicting postoperative pulmonary complications.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prediction 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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients undergoing respiratory function tests undergoing surgery
Key exclusion criteria	Postoperative respiratory management cases
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Yumi Middle name Last name Obata
Organization	St.Marianna University school of Medicine
Division name	Anesthesiology
Zip code	2168511
Address	Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL	0449778111
Email	y2obata@marianna-u.ac.jp

Public contact
Name of contact person	1st name Yumi Middle name Last name Obata
Organization	St Marianna university school of medicine St Marianna university school of mediciney yokohama city s
Division name	Anesthesiology
Zip code	2168511
Address	Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL	0449778111
Homepage URL
Email	y2obata@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University school of Medicine
Institute
Department

Funding Source
Organization	St.Marianna University school of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Marianna University school of Medicine
Address	Sugao2-16-1 Miyamae Kawasaki Kanagawa
Tel	0449778111
Email	http://marianna-net.marianna-u.ac.jp/kenkyusienbu/seimeirinri/IRB. htm

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	聖マリアンナ医科大学

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2021 Year 12 Month 21 Day
Date of IRB	2021 Year 12 Month 21 Day
Anticipated trial start date	2021 Year 12 Month 21 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 11 Month 09 Day
Last modified on	2021 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052532