Investigating the use of a breathing device in older people with broken ribs
| ISRCTN | ISRCTN14365105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14365105 |
| Integrated Research Application System (IRAS) | 349783 |
| Central Portfolio Management System (CPMS) | 64921 |
| National Institute for Health and Care Research (NIHR) | 208172 |
| Sponsor | North Bristol NHS Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 15/01/2026
- Registration date
- 06/02/2026
- Last edited
- 06/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Thousands of older people are taken to hospital each year with broken ribs. They are painful and can make it harder to take a deep breath or cough. Over half of older people with broken ribs develop problems, like chest infections, because they can’t take deep breaths. We think that a breathing exercise device called an incentive spirometer may help to prevent these problems. The incentive spirometer helps people take a deeper breath. Incentive spirometers are already given to some patients who have had an operation. They aren’t used everywhere for patients with broken ribs because we don’t know yet whether they help with recovery.
Who can participate?
Patients aged 65 years or older attending the Emergency Dept who have a chest injury such as broken ribs
What does the study involve?
Participants are split into two groups by chance. Both groups will be treated in the normal way whilst in hospital, including being taught breathing exercises, but one group will also be given an incentive spirometer to use. We will ask this group to try and use the incentive spirometer regularly throughout the day for at least the first 3 days after they come into hospital. We will ask permission from patients (or their carers) to collect information from their hospital notes about their recovery. We will look to see whether people who use the device get fewer problems, like chest infections, in the first 5 days after they come to hospital. We will also ask everyone to complete questionnaires to see how well they are recovering.
What are the possible benefits and risks of participating?
We cannot promise that the study will benefit patients directly, but it will help us decide on the best ways to care for people with broken ribs in the future. The benefit to patients, the NHS and society is that at the end of the study, it will be known if incentive spirometers reduce health complications in patients with broken ribs. In recognition of the patient's time, we will offer £20 vouchers on day 5 after the completion of all patient questionnaires.
Given that some NHS hospitals already safely use incentive spirometers and some do not, there are unlikely to be any risks. However, because we are using them in injured patients, the safety of all participants will be closely monitored by an independent group of experts.
Where is the study run from?
The study is being coordinated by Bristol Trials Centre on behalf of the study Sponsor organisation at North Bristol NHS Trust (UK)
When is the study starting and how long is it expected to run for?
March 2026 to March 2027
Who is funding the study?
National Institute for Health and Social Care (NIHR), Research for Patient Benefit (RfPB) (UK)
Who is the main contact?
Stephen Palmer, resolve-trial@bristol.ac.uk
Contact information
Scientific, Principal investigator, Public
Bristol Trials Centre
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
 ORCID ID |
0000-0002-8637-7284 |
|---|---|
| Resolve-trial@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Treatment, Prevention, Process of Care, Education or Self-Management, Device, Management of Care, Rehabilitation |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 48843_PIS - DETAILED_V.0_16Dec2025.docx |
| Scientific title | Randomised Evaluation of incentive Spirometry in OLder adults with rib fractures to preVEnt pulmonary complications: RESOLVE |
| Study acronym | RESOLVE |
| Study objectives | Primary Objective: To compare the effect on pulmonary complications of usual care plus incentive spirometry compared with usual care without incentive spirometry, at 5 days post randomisation. Secondary Objective: To compare the effect on patient-reported outcome measures of breathlessness and pain 5 days post randomisation, and the length of initial hospital stay, the rate of admission to critical care, mortality and hospital readmission rates within 30 days of randomisation. |
| Ethics approval(s) |
Approved 26/01/2026, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)2071048083; bradfordleeds.rec@hra.nhs.uk), ref: 26/YH/0013 |
| Health condition(s) or problem(s) studied | Rib fractures |
| Intervention | In open, participating centres, staff will monitor admissions to the Emergency department to screen for suitable patients. Any patients who are 65 or older with suspicion of chest wall trauma will be considered, and those who go on to have a confirmed rib fracture will be given a summary information sheet and access to a patient video. The site staff will confirm eligibility and then approach the patient for consent. In any case where the patient is without capacity to consent, a consultee or personal legal representative (PLR) will be approached. A detailed information sheet can be provided if requested and there will be an opportunity to ask questions with the site staff member. When consent is received via a signed paper form, the delegated ED staff member can access a REDCap database and add a new participant. They will need to complete the screening information, confirming eligibility, and confirm consent has been received. Before randomisation, they will need to add the minimisation factors; who consented (patient or consultee/PLR), and whether the patient has isolated rib fractures, or rib fractures plus other injuries. The details in REDCap will then be transmitted to Sealed Envelope and a randomisation allocation will be returned. If usual care without the use of an incentive spirometer is returned, then the patient will be informed and treated according to usual care. This will include treatment for their injuries and any breathing instructions given as part of standard care. If usual care plus use of an incentive spirometer is returned, they will be informed, and an initial face-to-face training session on use of the device will be delivered by the trained site staff. If the patient is deemed to be able to use the device independently (or in the case of patients lacking capacity, their consultee/PLR is deemed to be able to support the patient independently), they will continue to use the device, 3 times a day, for 5 days. However, the trained staff may feel that additional training sessions are needed for some patients and/or consultee/PLR's supporting patients. In those case, an additional two training sessions may be offered, up to a maximum of 3. Patients receiving the intervention will be provided with an education leaflet and a diary. They will be asked to complete this over 5 days to document their adherence. This diary will be collected by site staff and entered into the REDCap database after 5 days, where a patient is still an inpatient. If the patient does get discharged within 5 days, the diary will be collected on discharge. Adherence data may be collected from observation by site staff, where feasible and where needed. All trial patients will be asked to complete questionnaires on their pain and breathlessness at the point of consent. If this is not feasible, due to patient fatigue for example, this can be delayed but should still be completed within 24 hours of hospital admission. The forms may be completed with the support of a research/clinical staff member or a person with caring responsibility. For patients who remain an inpatient at day 5 (+ 2 days tolerance given in case this falls on a weekend) post randomisation, follow-up questionnaires will be requested and entered into the database by the delegated trial staff. For patients who have been transferred or discharged, the research staff will contact the patient or their consultee/PLR by telephone to complete these remotely. Patients will be offered a £20 voucher upon completion of both of the above sets of questionnaires. The REDCap database will need to be completed by a delegated staff member to add details of the patient's Baseline data, e.g. details of their injuries, standard care received or dates and times of training sessions. A follow-up data collection will take place at 5 days after randomisation, where details comprising the primary and secondary outcomes will be captured in the REDCap database. At 30 days post randomisation, research staff at the site will use hospital medical records to complete data collection on mortality and hospital readmissions. This will not involve contacting the patient or their consultee/PLR. Any safety events that occur between randomisation and Day 30 will be captured on safety forms in the patient database and reported to the sponsor within 24 hours of the site staff becoming aware of the event. Patients or their consultee/PLR will have the right to withdraw from any or all aspects of the trial at any time. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. Breathlessness measured using patient-reported outcomes in the Dyspnea-12 Questionnaire at Baseline and Day 5(+2) |
| Completion date | 30/03/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 276 |
| Key inclusion criteria | 1. Aged >=65 years 2. Radiological evidence of acute rib fracture(s) 3. Planned for admission 4. Has capacity to provide informed consent or personal consultee/legal representative available and able to support use of incentive spirometer |
| Key exclusion criteria | 1. Coexisting injury or condition for which treating clinician deems patient unable to use incentive spirometer (e.g. facial injuries; burns to both hands; advanced dementia) 2. Patients who have Sp02 <92% on air at time of screening (< 88% for known chronic lung disease) 3. Intubated 4. Haemodynamic instability (e.g severe hypo- or hypertension, significant atrial/ventricular arrhythmia) 5. History of eye, inner ear or brain surgery within previous 4 weeks (Contraindication to using incentive spirometry) |
| Date of first enrolment | 01/03/2026 |
| Date of final enrolment | 28/02/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
Study participating centres
Hills Road
Cambridge
CB2 0QQ
England
Tonna Uchaf
Tonna
Neath
SA11 3LX
Wales
2-4 Waterloo Place
Edinburgh
EH1 3EG
Scotland
Hayfield Road
Kirkcaldy
KY2 5AH
Scotland
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 16/12/2025 | 30/01/2026 | No | Yes |
| Participant information sheet | version 1.0 | 16/12/2025 | 30/01/2026 | No | Yes |
| Protocol file | version 1.0 | 16/12/2025 | 30/01/2026 | No | No |
Additional files
- 48843_PROTOCOL_V1.0_16Dec2025.pdf
- Protocol file
- 48843_PIS - DETAILED_V.0_16Dec2025.docx
- Participant information sheet
- 48843_PIS - SUMMARY_V1.0_16Dec2025.docx
- Participant information sheet
Editorial Notes
15/01/2026: Study's existence confirmed by the NIHR.
