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The influence of the Breazy-application on outcomes of patients admitted with one or more rib fractures; a randomized controlled trial (RIB-Breazy)

The influence of the Breazy-application on outcomes of patients admitted with one or more rib fractures; a randomized controlled trial (RIB-Breazy) - RIB-Breazy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57567
Enrollment
100
Registered
2025-04-29
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Rib fracture Thoracic injury

Interventions

One group will use the BREAZY-app, the other group will not.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age 16 years or older 2) Admitted to the hospital with one or more rib fractures 3) Blunt force trauma 4) Hospital presentation <72h after trauma 5) Eligible to use the Breazy app in the judgment of the attending physician 6) Provision of informed consent by patient

Exclusion criteria

Exclusion criteria: 1) Planned transfer to other hospital <24 hours after admission 2) Rib fractures due to cardiopulmonary resuscitation 3) Previous rib fractures or pulmonary problems, requiring continuous oxygen  use at home pre-trauma 4) Congenital thoracic deformity (pectus excavatum, pectus carinatum, severe  scoliosis or kyphosis) 5) Inhalation trauma or severe burns close to or inside mouth or neck 6) Insufficient comprehension of Dutch or English language to understand the  study documents, physical therapy instructions, and Breazy app instructions  (only in 2nd study group) in the judgment of the attending physician  7) Unable to use Breazy app (only in 2nd study group) 8) Participation in another surgical intervention or drug study that might  influence any of the outcome parameters

Design outcomes

Primary

MeasureTime frame
HLOS

Secondary

MeasureTime frame
All patients: 1) Occurrence of pneumonia within 30 days after trauma 2) pulmonary function 3) SCARF score 4) level of thoracic pain and analgesics use 5) ICU admission 6) ICU LOS 7) mechanical ventilation 8) mechanical ventilation duration 9) mechanical ventilation-free days 10) patient satisfaction with pulmonary exercise support. Additional for the Breazy group: 1) time per day that patients use the app during admission 2) to what degree patients think the Breazy app helped them improve their respiratory status.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)