Pulmonary CT in Pneumonia Complicating Stroke

NCT03106909 | Completed

• 1 other identifier: 213436
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes. Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as several issues potentially confound diagnosis. Chest X-ray (CXR), a central component in the diagnostic work-up, may have limited utility in the early stages as they are often of suboptimal quality, and infrequently confirm typical diagnostic infiltrates. Blood biomarkers of the stress-immune response have received considerable attention, but interpretation has been limited by differing methodologies, including definition of pneumonia. Bacterial organisms in the oral cavity may also be of relevance as biomarkers of post-stroke pneumonia. Major challenges facing frontline clinicians are therefore whether to initiate antibiotics; if so, when and for how long. These issues have antibiotic stewardship implications for clinicians in terms of potential for under-treatment or over-treatment with antibiotics based on CXR appearances. Pulmonary Computed Tomography (CT) could be of value as a radiological reference standard when pneumonia is suspected after stroke, and enable more rigorous evaluation of the diagnostic performance of CXR (and other candidate biomarkers) to inform decision-making when pneumonia is suspected. The overall primary aim is therefore to investigate the feasibility and reliability of using pulmonary CT as a radiological reference standard for evaluating suspected pneumonia complicating stroke. The secondary aims are to explore the diagnostic accuracy of CXR and blood biomarkers (index tests) when pneumonia is suspected during hospital admission after stroke using pulmonary CT as a reference standard.

Conditions

Stroke; Pneumonia

Keywords

stroke; pneumonia; biomarkers; pulmonary CT

Outcome Measures

Primary Outcomes (2)

• Proportions of eligible participants from screening; eligible participants declining participation (and reasons)

  18 months

• Proportion of participants undergoing pulmonary CT

  Participants scanned and reasons for not scanning

  18 months

Secondary Outcomes (17)

• Proportion of consenting participants undergoing repeat CXR when indicated

  18 months

• Proportion with changes consistent with pneumonia on CXR; proportion with changes consistent with pneumonia on pulmonary CT

  18 months

• Proportion participants with changes consistent with pneumonia on pulmonary CT

  18 months

• Characteristics and distribution of radiological changes consistent with pneumonia on pulmonary CT

  18 months

• Spectrum of additional radiological findings on pulmonary CT

  18 months

Interventions

pulmonary computed tomography (CT) RADIATION

Pulmonary CT imaging

Eligibility Criteria

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

Study Population

Inpatient stroke service at Salford Royal Foundation Trust (SRFT) and Royal Stoke University Hospital (RSUH)

You may qualify if:

• Inpatient in SRFT or RSUH with diagnosis of stroke current admission
• Within 24h of clinically suspected pneumonia occurring after admission
• Aged ≥18y
• Provision of informed consent from participant or personal consultee
• Able to undergo pulmonary CT within next 48h

You may not qualify if:

• Treatment for lower respiratory tract infection (LRTI) completed within the preceding month
• Mechanical ventilation planned or anticipated imminently
• End-of-life care planned or anticipated imminently

Sponsors & Collaborators

• Natalie Garratt: lead

Study Sites (2)

Salford Royal Nhs Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Pneumonia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• CRAIG SMITH

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research & Development Lead

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: April 11, 2017
• Study Start: April 10, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)