Effect of Mechanical Ventilation on the Incidence of Pneumothorax After Subclavian Vein Catheterization

April 19, 2016 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients undergoing neurosurgery that requires the placement of subclavian venous catheterization

Exclusion Criteria:

  • infection over the puncture site
  • history of prior clavicular fracture
  • anatomical anomaly of subclavian vein
  • Pneumothorax

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ventilated group
Lungs were mechanically ventilated during subclavian vein catheterization.
Other: Lungs were mechanically ventilated during subclavian vein catheterization
Ventilated group
Active Comparator: Control group
Lungs were not mechanically ventilated during subclavian vein catheterization.
Other: Lungs were not mechanically ventilated during subclavian vein catheterization
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of pneumothorax
Time Frame: an expected average of one day after surgery
Postoperative chest X-ray will be taken to check for the occurence of pneumothorax.
an expected average of one day after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
catheterization success rate
Time Frame: an expected average of one day after surgery
an expected average of one day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • H-1301-066-459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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