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

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 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


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

Value
https://center6.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