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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044412
Receipt No. R000050735
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
Date of disclosure of the study information 2021/06/03
Last modified on 2021/06/03

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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
2021 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
2021 Year 06 Month 03 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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