UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029355 |
|---|---|
| Receipt number | R000033510 |
| Scientific Title | Comparison of aeration loss severity of transthoracic lung ultrasound between pressure-controlled volume guaranteed(PCV-VG) and volume-controlled ventilation(VCV) after hip joint surgery in elderly patients , and correlation with pulmonary function test |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/06/24 11:06:30 |
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Basic information
Public title
Comparison of aeration loss severity of transthoracic lung ultrasound between pressure-controlled volume guaranteed(PCV-VG) and volume-controlled ventilation(VCV) after hip joint surgery in elderly patients , and correlation with pulmonary function test
Acronym
pulmonary function change between pressure-controlled volume guaranteed(PCV-VG) and volume-controlled ventilation(VCV) after hip joint surgery in elderly patients
Scientific Title
Comparison of aeration loss severity of transthoracic lung ultrasound between pressure-controlled volume guaranteed(PCV-VG) and volume-controlled ventilation(VCV) after hip joint surgery in elderly patients , and correlation with pulmonary function test
Scientific Title:Acronym
pulmonary function change between pressure-controlled volume guaranteed(PCV-VG) and volume-controlled ventilation(VCV) after hip joint surgery in elderly patients
Region
| Asia(except Japan) |
Condition
Condition
Elderly patients (65-90 years of age) who were planned hip joint surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
aeration loss severity of transthoracic lung ultrasound between pressure-controlled volume guaranteed(PCV-VG) and volume-controlled ventilation(VCV) after hip joint surgery in elderly patients , and correlation with pulmonary function test
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point of this study was the comparison the degree of atelectasis in lung ultrasound score (LUS score) between at the time point of before and after surgery in the elderly patients. We also compared the degree of atelectasis and the degree of difference in lung function between the two groups (Group V, Group P) before and after the operation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
pressure-controlled volume guaranteed(PCV-VG) ventilator application
Interventions/Control_2
volume-controlled ventilation(VCV) ventilator application
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly patients who were aged from 65 to 90 and scheduled for the hip joint surgery
Key exclusion criteria
- Patients who refuse to participate in the study
- Preoperative hemodynamically unstable condition
- Patients with a body mass index (BMI) greater than 31 kg / m2
- Patient with history of intra-thoracic procedure
- Patients with mental retardation
- Patients with severe cognitive impairment
- Patients who cannot understand Korean
Target sample size
88
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
82226261437
Homepage URL
moma2@naver.com
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
Funding Source
Organization
Korea University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Korea university Guro hosital
Address
gurodong ro 148
Tel
02-2626-1437
kughirb@naver.com
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
| 2018 | Year | 10 | Month | 01 | 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
76
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033510
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/06/24 | PCVVCV elderly.xlsx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/06/26 | PCVVCV elderly.xlsx |
