Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00915161
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition
Pleural Effusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients: an Observational Single Centre Cohort Study

Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • The ratio of Partial pressure of oxygen to inspired concentration of oxygen (P:F ratio) [ Time Frame: pre-procedure, 30 minutes, 4,8,24 and 48 hours post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects on A-a gradients, dead space ventilation, ventilator settings and dynamic compliance [ Time Frame: pre-procedure, 30minutes, 4,8,24 and 48 hours post procedure ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

This will be a collection of data in patients in whom it has been decided by the attending clinician that pleural drainage would be beneficial. Ultrasound will be used to confirm the presence of pleural effusion and to estimate the size of the pleural effusions and to confirm the position of the pleural drain. Data will be collected before drainage, 30 minutes after drainage and then at 4,8,12 and 24 hours after the insertion of the drain (please see also attached summary of investigations). Measurements will include arterial blood gas analysis drawn from an indwelling arterial catheter, blood pressure, pulse, respiratory rate, mixed, expired CO2 and ventilator settings. The measurements will stop either at the end of the 48 hour period or when the team caring for the patient chose to remove the drain (whichever is the first).

All measurements including the arterial blood gas analysis form part of the standard care of an ICU patient. The arterial blood gas measurements are withdrawn from an indwelling arterial catheter which is routinely in place on all ICU patients. Only the use of thoracic ultrasound by a trained ultrasonographer both before and after the procedure will be additional to the standard care of the patient. The use of Chest X-rays is at the discretion of the treating clinician and does not form part of the study protocol. Standard biochemical, microbiological and cytological tests will be performed on the pleural fluid and blood in keeping with the standard practice for pleural effusions.

The primary outcome measure is the effects of drainage on the P:F ratio. measures of dead space ventilation, A-a gradiants, ventilator settings and dynamic compliance will also be assessed

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Coagulopathy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00915161

Locations
United Kingdom
John Radcliffe hospital
Oxford, Oxon, United Kingdom, OX39DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: andrew p walden, PhD Oxford University Hospitals NHS Trust
  More Information

No publications provided by Oxford University Hospitals NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heather House, Oxford Radcliffe Research and Development
ClinicalTrials.gov Identifier: NCT00915161     History of Changes
Other Study ID Numbers: MREC-07/H0505/197
Study First Received: June 4, 2009
Last Updated: June 4, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Oxford University Hospitals NHS Trust:
ventilation
oxygenation

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014