Pleural EffusionNCT00915161
Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients
An observational study of Pleural Effusion, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pleural Effusion
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on Mechanical ventilation with evidence of pleural effusion on CXR confirmed with bedside ultrasound
Who may be able to join
- 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
Who cannot join
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients: an Observational Single Centre Cohort Study
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.
Read the 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
- Conditions
- Pleural Effusion
- Keywords
- ventilation, oxygenation
- Medical subject headings
- Pleural Effusion, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of Partial pressure of oxygen to inspired concentration of oxygen (P:F ratio)
Measured: 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
Measured: pre-procedure, 30minutes, 4,8,24 and 48 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- andrew p walden, PhD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915161
- Sponsor's protocol ID
- MREC-07/H0505/197
- Status last verified
- Jun 2009
- First submitted
- 4 Jun 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20646244
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Effects of Thoracocentesis in Mechanically Ventilated Patients: an Observational Single Centre Cohort Study
- ClinicalTrials.gov ID
- NCT00915161
- Acronym / sponsor ID
- MREC-07/H0505/197
- Conditions
- Pleural Effusion
- Keywords
- ventilation, oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on Mechanical ventilation with evidence of pleural effusion on CXR confirmed with bedside ultrasound
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
- Derived from this study: PubMed 20646244Walden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
andrew p walden, PhD principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2009.