UMIN-CTR Clinical Trial

Basic information
Public title	Pulmonary complications and clinical outcomes using ultrasound according to the inspired oxygen concentration during general anesthesia in elderly patients: Multi-center, randomized controlled trials
Acronym	Pulmonary complications and clinical outcomes using ultrasound according to the inspired oxygen concentration during general anesthesia in elderly patients: Multi-center, randomized controlled trials
Scientific Title	Pulmonary complications and clinical outcomes using ultrasound according to the inspired oxygen concentration during general anesthesia in elderly patients: Multi-center, randomized controlled trials
Scientific Title:Acronym	Pulmonary complications and clinical outcomes using ultrasound according to the inspired oxygen concentration during general anesthesia in elderly patients: Multi-center, randomized controlled trials
Region	Asia(except Japan)

Condition
Condition	Patients aged more than 65 years who are undergoing lower extremity surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study aims to compare the pulmonary complications and clinical outcomes using lung ultrasound between conventional high inspired oxygen concentration group and low physiologic low inspired oxygen concentration group in patients receiving lower extremity surgery
Basic objectives2	Others
Basic objectives -Others	the pulmonary complications(atelectasis, pneumonia) using lung ultrasound according to inspired oxygen concentration
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of atelectasis assessed by Lung ultrasound score (LUS) score
Key secondary outcomes	1) The prevalence of the abnormal findings (e.g. pneumonia) 2) The relationship between postoperative pulmonary complication and ABGA, CXR changes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Physiologic low inspired oxygen concentration (FIO2 0.4) during general anesthesia
Interventions/Control_2	Conventional high inspired oxygen concentration (FIO2 0.5-1.0) during general anesthesia
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients undergoing lower extremity surgery
Key exclusion criteria	- Patients who refuse to undergo lung ultrasound, refusing to participate in the study - Preoperative hemodynamically unstable condition -Patients with preoperative lung abnormalities such as pneumonia, atelectasis, or previous intrathoracic procedures -consistent hypoxia even with therapy for hypoxia - patients with difficult airway - Patients with mental retardation - Patients who can not read and understand Korean
Target sample size	142

Research contact person
Name of lead principal investigator	1st name Young Ju Middle name Last name Won
Organization	Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	08308
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL	82-2-2626-1437
Email	moma2@naver.com

Public contact
Name of contact person	1st name Young Ju Middle name Last name Won
Organization	Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	08308
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL	82-2-2626-1437
Homepage URL
Email	moma2@naver.com

Sponsor
Institute	Korea University
Institute
Department

Funding Source
Organization	none
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	Korea University Guro Hospital Institutional Review Board, Seoul, Republic of Korea
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
Tel	82-2-2626-1632
Email	eirbadmin@kumc.or.kr

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	2021 Year 06 Month 03 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	Enrolling by invitation
Date of protocol fixation	2021 Year 01 Month 19 Day
Date of IRB	2021 Year 01 Month 19 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2022 Year 06 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 03 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050735