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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029355
Receipt No. 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 2017/09/29

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

Public contact
1st name of contact person
1st name
Middle name
Last name Young ju Won
Organization Guro Hospital, Korea University College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82226261437
Homepage URL
Email moma2@naver.com

Sponsor
Institute Korea University
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 29 Day
Last follow-up date
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
2017 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033510

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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