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Investigating the use of a breathing device in older people with broken ribs

Randomised Evaluation of incentive Spirometry in OLder adults with rib fractures to preVEnt pulmonary complications: RESOLVE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14365105
Enrollment
276
Registered
2026-02-06
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rib fractures Injury, Occupational Diseases, Poisoning

Interventions

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
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 an

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Current key exclusion criteria as of 25/08/2026: 1. Co-existing 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. Evidence of established acute pulmonary complication developing after rib fracture injury requiring active treatment (e.g. pneumonia requiring antibiotic treatment, respiratory failure requiring ventilatory support) 3. Haemodynamic instability (e.g. severe hypo- or hypertension, significant atrial/ventricular arrhythmia) 4. History of eye, inner ear or brain surgery within previous four weeks (Contraindication to using incentive spirometry) Previous 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)

Design outcomes

Primary

MeasureTime frame
Respiratory infection measured using medical notes at Day 5;Respiratory failure measured using medical notes at Day 5;Plural effusion measured using medical notes at Day 5;Atelectasis measured using medical notes at Day 5;Pneumothorax measured using medical notes at Day 5;Death measured using medical notes at Day 5;Additional pulmonary related events measured using GP records at Day 5

Secondary

MeasureTime frame
1. Breathlessness measured using patient-reported outcomes in the Dyspnea-12 Questionnaire at Baseline and Day 5(+2) 2. Pain measured using patient-reported outcomes in a numerical pain scale at Baseline and Day 5(+2) 3. Patient length of hospital stay recorded in medical notes at Day 30 4. Admission to critical care recorded in medical notes at Day 30 5. Mortality in medical notes at Day 30 6. Hospital readmissions in medical notes at Day 30

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactStephen Palmer
Resolve-trial@bristol.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 19, 2026