NCT00915161

Brief Summary

Collections of fluid around the lung (pleural effusions) are common in patients on mechanical ventilation. Long stays on mechanical ventilation can lead to serious complications such as pneumonia and are associated with significant morbidity and mortality. The drainage of pleural effusions may lead to improvements in oxygenation making it easier to discontinue mechanical ventilation. The purpose of this study was to examine the effects of thoracocentesis (pleural fluid drainage) on blood oxygenation over a 48 hour period to see whether the effects are sustained and therefore helpful in this discontinuation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
Last Updated

June 5, 2009

Status Verified

June 1, 2009

Enrollment Period

7 months

First QC Date

June 4, 2009

Last Update Submit

June 4, 2009

Conditions

Pleural Effusion

Keywords

ventilationoxygenation

Outcome Measures

Primary Outcomes (1)

  • The ratio of Partial pressure of oxygen to inspired concentration of oxygen (P:F ratio)

    pre-procedure, 30 minutes, 4,8,24 and 48 hours post procedure

Secondary Outcomes (1)

  • Effects on A-a gradients, dead space ventilation, ventilator settings and dynamic compliance

    pre-procedure, 30minutes, 4,8,24 and 48 hours post procedure

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on Mechanical ventilation with evidence of pleural effusion on CXR confirmed with bedside ultrasound

You may qualify if:

  • Patients on mechanical ventilation with evidence of pleural effusions on plain CXR confirmed to be large on bedside ultrasound in whom the attending clinician felt drainage would be beneficial

You may not qualify if:

  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe hospital

Oxford, Oxon, OX39DU, United Kingdom

Location

Related Publications (1)

  • Walden AP, Garrard CS, Salmon J. Sustained effects of thoracocentesis on oxygenation in mechanically ventilated patients. Respirology. 2010 Aug;15(6):986-92. doi: 10.1111/j.1440-1843.2010.01810.x. Epub 2010 Jul 20.

    PMID: 20646244DERIVED

MeSH Terms

Conditions

Pleural EffusionRespiratory Aspiration

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • andrew p walden, PhD

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

January 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 5, 2009

Record last verified: 2009-06

Locations

GB(1)