Lung Deflation in Pediatric Subclavian Vein Catheterization (SCVLD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jin-Tae Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01608503

First received: May 26, 2012

Last updated: April 20, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 26, 2012
Last Updated Date	April 20, 2013
Start Date ^ICMJE	May 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 30, 2012)	The distance between the pleura and the line of the imaginary needle pathway (DPI) [ Time Frame: Within 5 minutes ] [ Designated as safety issue: Yes ] The ultra-sonography probe was adjusted to obtain an image containing the long-axis cross section of SCV, the pleura, the clavicle, and the first rib. Images were recorded by the same physician during whole respiratory cycle with the probe held in the identical position. Imaginary lines for supraclavicular and infraclavicular approach were drawn, and distances from the pleura were measured. If the pleura touched the INP, the distance was recorded as positive value. If the pleura did not touch the INP, the distance was recorded as negative value.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01608503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 30, 2012)	The incidence of pleural movement over the imaginary needle pathway [ Time Frame: Within 5 minutes ] [ Designated as safety issue: Yes ] If the pleura touched the imaginary needle pathway, the incidence was checked.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Lung Deflation in Pediatric Subclavian Vein Catheterization
Official Title ^ICMJE	The Effect of Lung Deflation on the Position of the Pleura in Mechanically Ventilated Infants During Subclavian Vein Cannulation: an Ultrasound Study
Brief Summary	The subclavian vein (SCV) is a preferred site for placement of central venous catheter. However, pneumothorax is a major concern during subclavian venous catheterization. Lung deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the distance between the pleura and the SCV. The investigators evaluated the effect of lung deflation on the relative position between the pleura and the line of the imaginary needle pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV) using ultrasonography.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Pediatric Subclavian Vein Catheterization
Intervention ^ICMJE	Procedure: lung deflation lung was deflated during respiration cycle Procedure: lung inflation lung was inflated during respiratory cycle
Study Arm (s)	Experimental: respiration cycle lung inflation and deflation Interventions: Procedure: lung deflation Procedure: lung inflation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	41
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Pediatric patients who were scheduled for elective operation under general anesthesia Neonates (0 ~ 1 mo), Infants (1 mo ~ 1 yr) Exclusion Criteria: Structural anomalies of the chest wall History of lung and chest wall operations Prior central venous catheterization Upper respiratory tract infection, or pneumonia within 2 weeks
Gender	Both
Ages	up to 1 Year
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01608503
Other Study ID Numbers ^ICMJE	SVCLungDown
Has Data Monitoring Committee	Yes
Responsible Party	Jin-Tae Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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