Advanced Ultrasound in Pleural Infection (AUDIO)
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|ClinicalTrials.gov Identifier: NCT02608814|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 16, 2017
Pleural infection is a potentially serious infection of the fluid normally found around the lung and current evidence suggests its incidence is increasing in both adult and paediatric populations.
Identification of bacterial pathogens causing pleural infection is of paramount importance in the clinical care of patients are currently, only 40% of patients have a laboratory confirmed microbiological diagnosis for their pleural infection. An unclear diagnosis can be due to various reasons such as a small sample volume therefore the aim of the AUDIO study is to ascertain the capacity of pleural biopsies in improving the microbiological yield of pleural infection.
Currently, there are no well validated methods for identifying patients presenting with pleural infection on the basis of initial ultrasound imaging. The AUDIO study will define the role of baseline thoracic ultrasound in predicting the radiographic, clinical and surgical outcomes of patients with pleural infection.
The AUDIO study aims to recruit 50 patients from 2 centres with specific pleural expertise and these patients will be followed up over a 12 month period. Investigators hope that through the information gathered from ultrasound imaging and pleural biopsies, it will aid physicians' clinical and therapeutic decision making when treating patients with pleural infection.
|Condition or disease||Intervention/treatment||Phase|
|Pleural Infection||Procedure: Pleural biopsy sampling Other: Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Advanced Ultrasound in Pleural Infection|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||March 14, 2017|
|Actual Study Completion Date :||March 14, 2017|
- Procedure: Pleural biopsy sampling
6 - 8 pleural biopsy samples will be taken before the insertion of the chest drain. These samples will be sent to microbiology for examination.
- Other: Ultrasound
- To increase microbiological yield. [ Time Frame: Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid. ]
- Radiographic improvement in area of pleural collection measured by the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography. [ Time Frame: Day 1 and Day 7 ]
- Mortality from pleural infection [ Time Frame: 3 and 12 months ]
- Duration of hospital (in patient) stay [ Time Frame: From the date of initial hospital admission to the date of discharge assessed up to 2 weeks. ]
- Necessity for surgical fluid drainage documented in case report forms over study completion [ Time Frame: 3 and 12 months ]
- Pleural fluid drainage over 7 days [ Time Frame: First 7 days of trial involvement ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608814
|North Bristol NHS Trust, Southmead Hospital|
|Bristol, United Kingdom, BS10 5NB|
|Oxford Respiratory Trials Unit, Churchill Hospital|
|Oxford, United Kingdom, OX3 7LE|