Testing a breathing app for patients in the emergency room

CLinical Evaluation of a mobile App-based Respiratory device in the Emergency Department setting (CLEAR-ED)

Registry ID
ISRCTN66028175
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
electronRx Ltd
Enrollment
137
Start date
2025-11-27
Completion date
2026-10-30
Last update
2026-08-17

Conditions

Summary

Respiratory disease

Detailed description

There is no drug or other treatment involved in this study. It is a study to assess a new medical device compared to standard equipment. Once a participant has signed the Informed Consent form, they will be shown the new device and standard equipment. They will use the new device (purpleDx smartphone application) to measure their breathing over a 1-minute period. At the same time the nurse will count the number of breaths. This will be done three times. Next, the doctor or nurse will use the standard equipment (called a spirometer) to measure their breathing. This will be done three times. Then participants will use the new device to measure their heart rate over a 1-minute period. At the same time the nurse will use standard equipment (called a pulse oximeter) to measure their heart rate. This will be done three times. Lastly, participants will be given a short questionnaire with seven simple questions to say what they thought of using the new app.

Interventions

Inclusion criteria

Current inclusion criteria as of 24/10/2025: 1. Sex at birth classified as male or female 2. 18 years of age and above, presenting to Addenbrooke's Hospital Emergency Department 3. Able to read and understand the participant information sheet in English 4. Capacity and ability to sign an informed consent form 5. With or without respiratory or cardiorespiratory symptom/s Previous inclusion criteria: 1. Male or female 2. Aged 18 years and above, presenting to Addenbrooke's Hospital Emergency Department 3. Able to read/understand/write in English 4. With or without a medical diagnosis of respiratory or cardiopulmonary condition/s

Exclusion criteria

Current exclusion criteria as of 24/10/2025: 1. Unable to sit up i.e. cannot lie completely flat (supine) 2. Known pregnancy in women of child-bearing potential 3. Unable to comply with the requirements of the investigation in any way 4. Prisoners or young offenders Previous exclusion criteria: 1. Unable to sit up 2. Determined not to have capacity to provide consent to participate in the study 3. Known pregnancy in women of childbearing potential 4. Unable to comply with the requirements of the investigation in any way 4. Prisoners

Locations

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