RecruitingACTRN12618000736246

Can the levels of exhaled nitric oxide during an acute exacerbation of COPD predict which patients will be at higher risk of further hospital admissions over the next twelve months?

Expired Nitrous Oxide predicting ReADmission (NORAD) study: A prospective cohort study to evaluate fractional exhaled nitric oxide levels in hospitalised patients with acute exacerbations of chronic obstructive lung disease and the risk of hospital readmission.


Sponsor

St John of God Hospital Midland

Enrollment

80 participants

Start Date

May 30, 2018

Study Type

Observational

Conditions

Summary

Nitric oxide (NO) has been implicated in the pathophysiology of lung diseases. NO is produced in the lung and can be measured in exhaled breath. The measurement of fractional exhaled nitrous oxide (FeNO) has now been standardized and there is evidence regarding its clinical use in asthma. However, the exact clinical role of FeNO remains poorly investigated in the context of Chronic Obstructive Pulmonary Disease (COPD). COPD is a leading cause of disability and mortality. Patients with COPD are prone to recurrent exacerbations that can affect quality of life and lung function. Exacerbation prevention is therefore an important goal of COPD management. This study aims to clarify the role of FeNO measurement in the setting of hospitalized COPD exacerbations and assess its association with risk of readmission. Identifying patients at greater risk of readmission may potentially help target interventions in this population.


Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

COPD (chronic obstructive pulmonary disease) is a serious lung condition — often caused by long-term smoking — that makes breathing progressively harder. People with COPD frequently experience severe flare-ups (called exacerbations) that require hospital admission and can cause lasting damage to lung function. Identifying which patients are at highest risk of being readmitted to hospital after a flare-up could help target better follow-up care and prevent future episodes. This study is measuring a gas called exhaled nitric oxide (FeNO) in patients hospitalised with a COPD exacerbation. Nitric oxide is produced naturally in the lungs and its level can reflect inflammation. The researchers want to find out whether higher FeNO levels during a hospital admission predict a greater risk of coming back to hospital within the next year. You may be eligible if you are 40 years or older, have a significant smoking history (at least 15 pack-years), have confirmed or suspected COPD (with airflow obstruction on lung function testing), and are being admitted to hospital with a COPD exacerbation. People in acute respiratory failure requiring a breathing machine, those with additional lung conditions like bronchiectasis or pulmonary embolism, and interstate or overseas visitors are not eligible for this study, which is based at St John of God Hospital Midland.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study will assess the impact of fractional exhaled Nitric Oxide (FeNO) in people admitted to hospital with an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) on 12-month read

This study will assess the impact of fractional exhaled Nitric Oxide (FeNO) in people admitted to hospital with an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) on 12-month readmission risk for AECOPD. The FeNO will be measured once within 24 hours of admission using the NIOX VERO device. Additional known and hypothesised confounders of hospital readmission will be measured once within 24 hours of admission including 1) patient demographics, 2) Spirometry using the EasyOne Spirometer, 3) Severity of COPD using the COPD Assessment Test, 4) breathlessness using the Modified MRC dyspnoea scale, 5) medical co-morbidities using the Charlson Comorbidity Index, 6) anxiety using the Hospital Anxiety and Depression scale and 7) laboratory evidence of allergy and with blood eosinophil level, IgE level and RAST f or dust mite, pollen, animal and mould mix. These measurements will be administered in conjunction with a member of the study team (respiratory specialists or respiratory registrar or respiratory clinical nurse). Blood tests will be obtained from blood samples obtained at admission by emergency medicine staff as part of routine care. Any remaining blood tests will be additionally requested.


Locations(1)

St John of God Midland Public Hospital - Midland

WA, Australia

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ACTRN12618000736246


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