UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028449 |
|---|---|
| Receipt number | 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 16:08:39 |
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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
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
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032565
