Novel Sensors and Artificial Intelligence for Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis and Bronchiectasis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPapworth Hospital NHS Foundation Trust

About this trial

The goal of this observational study is to learn about new sensors that measure changes in the body that happen during a chest infection, such as breathing rate and heart rate. This study will be with adults who have either cystic fibrosis or bronchiectasis who start treatment with intravenous antibiotics (usually for around 2 weeks).

The main question it aims to answer is the change in sensor measure (such as heart rate) between the start and end of treatment for a chest infection.

No follow up visits are required for this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old

Diagnosis of CF based on genetic testing and /or sweat chloride levels or CT confirmed diagnosis of non-CF bronchiectasis

Under the care of Royal Papworth Hospital

Starting IV antibiotics for treatment of APE as defined by the Hill Criteria ²

Disqualifiers

Patients unable to provide written informed consent

Lung transplant recipients or on lung transplant waiting list

Use of long-term oxygen therapy (LTOT) or non-invasive ventilation to manage respiratory failure

Patients unwilling to consent to their link anonymised data from home monitoring being used for research

Trial population

Patients admitted under the specialist care of Royal Papworth Hospital Foundation Trust, Cambridge, UK

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    non-interventional

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

The change in physiological parameter measure such as heart rate (sensor dependant) between the start and end of intravenous antibiotics for acute pulmonary exacerbation.

mean of parameter (e.g. heart rate) taken from first 2 days of IV antibiotics vs the last 2 days of antibiotics will be compared

Time frame
from enrolment to the end of treatment at 14 days (may be 10-21 days depending on length of treatment course)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Papworth Hospital NHS Foundation Trust

Lead sponsor

LifeArc

Collaborator

University of Cambridge

Collaborator

Department of Health, United Kingdom

Collaborator

National Institute for Health Research, United Kingdom

Collaborator