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
  Purpose

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.


Condition Intervention
Pediatric Subclavian Vein Catheterization
Procedure: lung deflation
Procedure: lung inflation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Lung Deflation on the Position of the Pleura in Mechanically Ventilated Infants During Subclavian Vein Cannulation: an Ultrasound Study

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 41
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: respiration cycle
lung inflation and deflation
Procedure: lung deflation
lung was deflated during respiration cycle
Procedure: lung inflation
lung was inflated during respiratory cycle

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01608503

Locations
Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01608503     History of Changes
Other Study ID Numbers: SVCLungDown
Study First Received: May 26, 2012
Last Updated: April 20, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
subclavian vein
ultrasound
distance between the subclavian vein and the lung

ClinicalTrials.gov processed this record on July 23, 2014