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NIVO – 1 year longitudinal follow up after assisted ventilation

What is the purpose of the study?

COPD (Chronic Obstructive Pulmonary Disease) is a condition which involves the lungs, causing problems such as breathlessness, cough and phlegm production. Patients can experience episodes when their symptoms are worse than normal which may need hospital treatment. These are known as “flare-ups”, “lung attacks” or “exacerbations” and may or may not be complicated by pneumonia. During such episodes if waste gases build up a ventilator may be required to support the body’s breathing efforts. This ‘assisted ventilation’ can be in the form of a tube into the lungs called invasive ventilation (IV) or more commonly a tight mask worn over on the face called non-invasive ventilation (NIV).

At present, we know that assisted ventilation can be lifesaving but we do not understand what patients’ quality of life is like after they have been discharged from hospital. We are interested in understanding more about patients’ lives after an exacerbation of COPD which required assisted ventilation because this information will help inform discussions between doctors and patients.

We aim to track the progress of patients that have required assisted ventilation for one year after discharge from hospital. During this time we will collect information about living with COPD including its impact on ability to perform tasks, anxiety and depression levels and quality of life. Whether or not an individual would want to have assisted ventilation again in the future, should the need arise, will also be explored.

We believe that tracking answers over a period of time will give a more representative view of a patient’s experience rather than using a single time point.

 

Do I have to take part?

No, it is your free choice to take part. If you decide to take part you will be asked to sign a consent form. You are free at any time to withdraw from the study, and do not have to give a reason. If you decide to withdraw from the study, we will use the information we have gathered up to that point.

If you decide not to take part you will continue to receive the same standard of care.

What will happen if I choose to take part?

After a researcher has taken you through the consent process they will collect some additional information. We will use several questionnaires which assess the impact of COPD on your life, anxiety and depression levels and how much you can manage day to day. The researcher will also ask your attitude towards having assisted ventilation again in the future should the need arise.

We will ask you to fill in the same short questionnaires every month for 12 months with a researcher offering face to face advice at 3, 6 and 12 months. At these visits your weight, oxygen level and spirometry (basic blowing test) will be measured. Filling the forms takes less than 30 minutes.

What are the possible disadvantages and risks to taking part?

Other than taking up some of your time (which we will keep to a minimum) we foresee no potential harm to yourself by taking part.

What are the advantages to taking part?

As things stand little is formally known about the period after assisted ventilation. By taking part you will be helping to better inform healthcare professionals about ‘real world’ patient experiences after assisted ventilation. This information will then better inform discussions between patients and doctors.

Payment

Travel expenses will be reimbursed.

Will my personal information be kept confidential?

During the study we will collect information from you about your health and well-being. Your personal information such as your name and date of birth will be kept confidential and only available to the research team. The information given will only be used in a way that cannot be traced back to you, and any personal information will be stored securely. With your permission, we will write to your GP to let them know that you are in the study. No one outside the research team will know if you decide not to take part.

 

What will happen with the results of the study?

The results will be discussed at scientific medical meetings, and also will be published in medical journals so that others can learn from our findings. You can receive a copy of the results by contacting Dr Stephen Bourke or Dr Tom Hartley (whose details are at the end of this document). A summary of the trial findings will be posted on the Northumbria Trust’s website.

 

For more information contact:

Judith Moore, Clinical Trials Officer (0191) 404 1000 Ex 2263

Customer Services, (0191) 404 1072

 

Clinical Trials in Respiratory Disorders

Select a trial from the list below to find out more about what it’s all about and how you can get involved in helping others.

EMBARC – The European Bronchiectasis Registry

This study is seeking to establish a register of patients diagnosed with bronchiectasis around Europe.

EME – TIPAC – Idiopathic Pulmonary Fibrosis Study

Treating pulmonary fibrosis with co-trimoxazole

LuCID Lung Cancer Indicator Detection

The goal of this study is to carefully look at the compounds someone exhales to determine if analysis of exhaled breath can detect lung cancer.

NIVO – 1 year longitudinal follow up after assisted ventilation

This study aims to track the progress of patients that have required assisted ventilation for one year after discharge from hospital.

Instage-IPF IMP study

This study is for patients that have been diagnosed with Idiopathic pulmonary fibrosis.

MARS2

The aim of the MARS2 study is to determine if it is feasible to enrol patients with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and lung-sparing surgery.


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