UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044412 |
|---|---|
| Receipt number | 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 | 2022/07/08 10:26:25 |
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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
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
moma2@naver.com
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
