Evaluating the usefulness of CT-scans in the diagnosis and management of chronic obstructive pulmonary disease (COPD) patients with respiratory symptoms.
| ISRCTN | ISRCTN39235677 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39235677 |
| Secondary identifying numbers | Rescue_Version 3 |
- Submission date
- 01/12/2020
- Registration date
- 10/12/2020
- Last edited
- 19/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease (COPD) is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow. The main symptoms include shortness of breath and cough with sputum production. COPD is a progressive disease, meaning it typically worsens over time.
COPD is a major health problem worldwide accounting for more than 3 million deaths annually. Usually, COPD-related deaths occur during an acute exacerbation of COPD.
The primary objective of the proposed clinical trial is to evaluate the impact of a chest CT scan on the recovery of COPD patients having an exacerbation of their respiratory symptoms.
Who can participate?
People diagnosed or suspected with COPD, aged 40 years or above, with a smoking history of over 20 pack years
What does the study involve?
Patients will be randomized into two groups. Patients allocated in group A will have a CT scan whereas patients allocated in group B will have an x-ray. The study personnel will also perform follow-up phone calls and/or visits, as needed, to the patients to remind them to complete the EXACT. Furthermore, the patients will be monitored for adherence to treatment that have been given by the study physician after diagnosis.
What are the possible benefits and risks of participating?
There are no added risks to the patients as there is currently no clear guideline regarding the use or not use of CT scans during AECOPD. Emerging data suggest that there is a decrease in mortality in smokers who undergo CT scans as a control against bronchial carcinoma.
Where is the study run from?
University Hospital Basel, Clinic for Respiratory Medicine and Pulmonary Cell Research (Switzerland)
When is the study starting and how long is it expected to run for?
November 2019 to March 2024
Who is funding the study?
University Hospital Basel (Switzerland)
Who is the main contact?
Prof Daiana Stolz
dainana.stolz@usb.ch
Contact information
Scientific
University Hospital Basel
Clinic of Respiratory Medicine and Pulmonary Crell Research
Petersgraben 4
Basel
4031
Switzerland
 ORCID ID |
0000-0003-0099-882X |
|---|---|
| Phone | + 41 61 2655184 |
| daiana.stolz@usb.ch |
Public
University Hospital Basel
Clinic of Respiratory Medicine and Pulmonary Crell Research
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 61 328 69 17 |
|---|---|
| vivian.suarezdomenech@usb.ch |
Study information
| Study design | Multicenter randomized interventional controlled non-inferiority study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Respiratory Exacerbation Symptoms in COPD Undergoing Evaluation – The RESCUE study: Evaluating the usefulness of CT-scans in the diagnosis and management of COPD patients with exacerbations of respiratory symptoms. A randomised, interventional, controlled, non-inferiority study |
| Study acronym | RESCUE |
| Study objectives | The recovery of COPD patients, presenting at the emergency department, is similar between COPD patients who have a chest CT scan and COPD patients undergoing chest x-ray but who do not have a chest CT scan at presentation for an acute exacerbation of respiratory symptoms. |
| Ethics approval(s) |
Approved 12/12/2019, Ethikkomission Nordwest- und Zentralschweiz (EKNZ; Ethics Committee northwest- and central Switzerland) (Hebelstrasse 53, Basel, 4056, Switzerland; +41 (0)61 268 13 50; eknz@bs.ch), ref: 2019-01920 |
| Health condition(s) or problem(s) studied | Diagnosis and management of COPD patients with exacerbation of respiratory symptoms |
| Intervention | Patients will be randomized 1:1 and will be allocated in two groups. Patients allocated in group A will have a CT-scan whereas patients allocated in group B will have an x-ray. Patients from group B with a high probability of pulmonary embolism and D-dimers >0.5 μg/ml or CRP >25 mg/L or PCT >0.25 μg/L will also have a CT scan. All additional management of patients in both groups, will be based on current recommended clinical practice guidelines. In case of clinical indication, attending physicians will be able to diverge from the study protocol and perform thorax-CTs irrespective of study group randomization. At baseline, the following data will be collected: demographic data, medical history, comorbidities, medication, clinical assessment and laboratory values (CRP, pro-calcitonin, D-dimers, pro-BNP). The CAT, MMRC, as well as the DECAF score will be fulfilled. Furthermore, we will collect nasopharyngeal swabs and spontaneous sputum for microbiological and microbiome analysis. Serum samples will also be collected and properly stored for subsequent analysis. Chest radiography will be performed using a standardized protocol. At this stage, the attending emergency physician will provide the most probable diagnosis and will decide if patients will be discharged or admitted to the appropriate hospital unit where they will be treated according to unit procedures. The physician will also outline the therapeutic plan with bronchodilators, inhaled corticosteroids, antibiotics or anticoagulants. The therapeutic plan will include initiation of treatment as well as modification or discontinuation of an existing treatment. Patients will be instructed to fill in the EXACT questionnaire at admission and then on day 7, 14, 21, and 28, each evening before bedtime. The study personnel will also perform follow-up phone calls and/or visits (when patient is hospitalised), as needed, to the patients to remind them to complete the EXACT. Furthermore, the patients will be monitored for adherence to treatment that have been given by the study physician after diagnosis. Furthermore, using the COPD-version of our big imaging data analysis software based on Image J algorithms embedded in an Apache-Spark environment for large scale cloud computing (https://github.com/4Quant/COPD-staging), developed in cooperation with 4Quant (ETH spin-off in Zürich), we will evaluate the potential of quantitative imaging biomarkers in relation to patients’ management and recovery. The projecting value of a CT-scan in the accurate diagnosis and effective management of COPD patients will be assessed by evaluating the 7 days EXACT questionnaires. Patients will be asked to return to the hospital for a follow up at Day 30. Next to the clinical and lung functional evaluation, CAT, and MMRC will be fulfilled and nasopharyngeal swabs and spontaneous sputum for microbiological and microbiome analysis will be collected. Serum samples will also be collected and properly stored for subsequent analysis. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Length of hospital stay measured in days reviewing the medical records 2. Diagnosis and therapy recorded before radiographic finding, after radiographic finding and at discharge by the treating physician |
| Secondary outcome measures | 1. Symptoms measured using the EXACT score questionnaire at baseline, 7, 14, 21 and 28 days 2. COPD assessment test (CAT score questionnaire) at baseline and 30 (+7) days 3. Modified Medical Research Council (MMRC) dyspnea scale at 28 days 4. Circulating biomarkers of COPD severity and outcome measured using blood sample at 28 days 5. Mortality up to 30 (+7) days measured using patient records 6. DECAF score for acute exacerbation measured through Dyspnoea (Questionnaire), Eosinopenia (blood), Consolidation (radiographic finding), Acidaemia (blood gas analysis) and atrial fibrillation (electrocardiogram) at baseline |
| Overall study start date | 01/11/2019 |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 310 |
| Total final enrolment | 28 |
| Key inclusion criteria | 1. Diagnosed or suspected COPD 2. Able to give informed consent as documented by signature 3. Age ≥40 years 4. Smoking history ≥20 PY 5. Suspicion of exacerbation of respiratory symptoms |
| Key exclusion criteria | 1. Pregnant or lactating women 2. Inability or contraindications to undergo a CT-scan eg. pregnancy 3. Clinically significant concomitant diseases such as organ transplantation 4. Acute coronary syndrome – emergency angiography 5. Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. |
| Date of first enrolment | 15/01/2020 |
| Date of final enrolment | 01/03/2024 |
Locations
Countries of recruitment
- Germany
- Greece
- Switzerland
Study participating centres
Petersgraben 4
Basel
4031
Switzerland
Οδός Σταύρου Νιάρχου, 455 00 (Niarxou Avenue 455 00)
Ioannina
45110
Greece
Freiberg
97106
Germany
Sponsor information
Hospital/treatment centre
Clinic of Respiratory Medicine and Pulmonary Crell Research
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 612654422 |
|---|---|
| daiana.stolz@usb.ch | |
| Website | https://www.unispital-basel.ch/ |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Other non-profit organizations
- Alternative name(s)
- University Hospital Basel, University Hospital of Basel, The University Hospital Basel, Hôpital Universitaire de Bâle, L’Hôpital universitaire de Bâle, Das Universitätsspital Basel, UHB
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
19/12/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/11/2025 to 01/03/2024.
2. The overall study end date was changed from 31/12/2025 to 01/03/2024.
3. Total final enrolment added.
4. Germany was added to the countries of recruitment.
04/12/2024: Contact details updated.
20/11/2023: Internal review.
30/06/2023: The following updates have been made to the study record and the plain English summary updated accordingly:
1. The recruitment end date has been changed from 30/11/2023 to 30/11/2025.
2. The overall study end date has been changed from 31/12/2023 to 31/12/2025.
3. The intention to publish date has been changed from 31/12/2024 to 31/12/2026.
15/02/2023: The following updates have been made to the study record and the plain English summary updated accordingly:
1. The public contact was updated.
2. The overall trial end date has been changed from 31/01/2022 to 31/12/2023.
3. The recruitment end date has been changed from 31/12/2021 to 30/11/2023.
4. The University Hospital of Freiberg was added as a trial participating centre.
5. The intention to publish date has been changed from 31/12/2022 to 31/12/2024.
11/12/2020: Internal review.
04/12/2020: Trial’s existence confirmed by Ethikkomission Nordwest- und Zentralschweiz.
