Effect of Mechanical Ventilation on the Incidence of Pneu... | NCT01815801

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

NCT01815801

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 20, 2016Estimated

Enrollment

334Actual

Phase

Not Applicable

Conditions

Subclavian Vein Catheterization

Interventions

Lungs were not mechanically ventilated during subclavian vein catheterization
Lungs were mechanically ventilated during subclavian vein catheterization

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 19, 2013

First Submission Date that Met QC Criteria

Mar 20, 2013

First Posted Date

Mar 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jae-Hyon Bahk, MD, PhD, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

334Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ventilated group	Experimental	Lungs were mechanically ventilated during subclavian vein catheterization.	Other: Lungs were mechanically ventilated during subclavian vein catheterization
Control group	Active Comparator	Lungs were not mechanically ventilated during subclavian vein catheterization.	Other: Lungs were not mechanically ventilated during subclavian vein catheterization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lungs were not mechanically ventilated during subclavian vein catheterization	Other	Control group	Control group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Seoul		South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.