Advanced Ultrasound in Pleural Infection

NCT02608814 | Completed

• 1 other identifier: AUDIO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pleural Infection

Outcome Measures

Primary Outcomes (1)

• To increase microbiological yield.

  Positive microbiological results on pleural biopsy at baseline compared with positive microbiological results on pleural fluid.

Secondary Outcomes (5)

• Radiographic improvement in area of pleural collection measured by the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography.

  Day 1 and Day 7

• Mortality from pleural infection

  3 and 12 months

• Duration of hospital (in patient) stay

  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

  3 and 12 months

• Pleural fluid drainage over 7 days

  First 7 days of trial involvement

Interventions

Pleural biopsy sampling PROCEDURE

6 - 8 pleural biopsy samples will be taken before the insertion of the chest drain. These samples will be sent to microbiology for examination.

Ultrasound OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical presentation compatible with pleural infection
• A pleural fluid collection that may or (rarely according to clinical judgement) may not require drainage that meets at least one or more of the following criteria:
• Purulent
• Gram stain positive for bacteria
• Bacterial culture positive
• Acidic with a pH \<7.2
• Low pleural fluid glucose \<3mmol/L (\<55mg/dL)
• CT evidence of pleural infection (consolidation of underlying lung with enhancing pleural collection on contrast-enhanced CT)

You may not qualify if:

• Age \<18 years
• No pleural fluid available for analysis
• Previous pneumonectomy on the side of pleural infection
• Expected survival \<3 months due to co-morbid disease
• Inability to give informed consent.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

North Bristol NHS Trust, Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Oxford Respiratory Trials Unit, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: November 20, 2015
• Study Start: May 1, 2015
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

GB (2)