Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 The arterial blood gas measurements are withdrawn from an indwelling arterial catheter which is routinely in place on all ICU patients.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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Pleural Effusion

Clinical Trial Details

NCT number	NCT00915161
Study type	Observational
Source	Oxford University Hospitals NHS Trust
Contact
Status	Completed
Phase	N/A
Start date	January 2008
Completion date	August 2008

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.