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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028449
Receipt No. R000032565
Scientific Title Usefulness of transthoracic lung ultrasound for the diagnosis and comparison of perioperative pulmonary complications between the ipsilateral and contralateral side in young adolescents undergoling unilateral thoracoplasty during scoliosis surgery
Date of disclosure of the study information 2017/08/04
Last modified on 2018/05/08

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Basic information
Public title Usefulness of transthoracic lung ultrasound for the diagnosis and comparison of perioperative pulmonary complications between the ipsilateral and contralateral side in young adolescents undergoling unilateral thoracoplasty during scoliosis surgery
Acronym Usefulness of transthoracic lung ultrasound for the diagnosis and comparison of perioperative pulmonary complications between the ipsilateral and contralateral side in young adolescents undergoling unilateral thoracoplasty during scoliosis surgery
Scientific Title Usefulness of transthoracic lung ultrasound for the diagnosis and comparison of perioperative pulmonary complications between the ipsilateral and contralateral side in young adolescents undergoling unilateral thoracoplasty during scoliosis surgery
Scientific Title:Acronym Usefulness of transthoracic lung ultrasound for the diagnosis and comparison of perioperative pulmonary complications between the ipsilateral and contralateral side in young adolescents undergoling unilateral thoracoplasty during scoliosis surgery
Region
Asia(except Japan)

Condition
Condition Patients who are undergoing elective scoliosis
Classification by specialty
Anesthesiology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate the changes between preoperative and postoperative ultrasonographic pulmonary findings of patients undergoing general anesthesia in scoliosis correction combined thoracoplastic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The LUS score of the lung ultrasound at the time point of preoperation, post operation, after general anesthesia was used to compare the degree of ventilation between thoracoplasty lung and the other side lung.
Key secondary outcomes 1) The prevalenve of the abnormal findings (hemothorax, atelectasis, pneumothorax, etc.).
2) The relationship between postoperative pulmonary complication and atelectasis score of pulmonary ultrasonography is examined.
3) Whether thoracoplasty level or scoliosis correction level is related to pulmonary ultrasound evaluation value.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Lung ultrasound sonograph was performed at the time point pre-operation, post operation, and recovery of general anesthesia period.
Interventions/Control_2
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
13 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria patients admitted to undergo elective scoliosis correction and thoracoplasty surgery.
Key exclusion criteria - Patients who refuse to undergo pulmonary ultrasound, refusing to participate in the study
- Preoperative hemodynamically unstable condition
- Patients with a body mass index (BMI) greater than 30 kg / m2
-medical history of intra thoracic procedure
- Patients with severe pulmonary disease (forced expiratory volume in 1 second less than 30% of predicted value)
- Patients who can not perform artery cannulation
- Patients with mental retardation
- Patients who can not read and understand Korean
Target sample size 29

Research contact person
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
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 82-2-2626-1437
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
2017 Year 08 Month 04 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information LUS score (by lung ultrasound sonograph) would be assessed at the time point pre-operation, post operation, recovery phase.
So we will compare the lung status between thoracoplasy lung and contralateral lung at the three time point.

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032565

Research Plan
Registered date File name
2018/05/08 scoliosis cw.xlsx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/05/08 scoliosis cw.xlsx


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