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OpenTrials
Completed

NCT Number: NCT00915161

Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John Radcliffe hospital

Oxford, Oxon, OX39DU, United Kingdom

About this study

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 The arterial blood gas measurements are withdrawn from an indwelling arterial catheter which is routinely in place on all ICU patients.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study title

Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients: an Observational Single Centre Cohort Study

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 5, 2009
Registry last updated
Jun 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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