No registrations found.
ID
Source
Brief title
Health condition
rib fracture; blunt thoracic trauma; nonoperative; rib fracture fixation; hospital length of stay; intensive care unit length of stay
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Intensive care unit length of stay for patients with a flail chest
- Hospital length of stay for patients with multiple rib fractures
Secondary outcome
- Numerical rating scale (NRS) for pain on day 3, 5, 7 and 14
- Pneumonia during hospital stay; date of pneumonia
- In hospital mortality
- Days of epidural / IV / systematic analgesia (morphine)
- Number of days admitted to Intensive Care Unit (ICU)
- Number of days on mechanical ventilation`
- Number of days in need oxygen therapy
- Vital capacity
- Tracheostomy yes / no
- Number of complications during admission
- Total number of days admitted in the hospital
- Quality of life as measured with EQ5D-5L 1 year after trauma
- Lung function related problems as measured with the mMRC 1 year after trauma
- Implant related complaints and removal yes / no
- Cost-effectiveness of rib fixation
- Chest tube yes/no
Background summary
Patients with thoracic injury and multiple rib fractures are at high risk of serious health outcomes. Nonoperative treatment for flail chest and multiple rib fractures has been the gold standard but there is an increasing popularity for rib fracture fixation in the last two decades, however, the literature remains scarce. The aim of this large multicentre prospective cohort study is to compare rib fixation with nonoperative treatment for flail chest or multiple rib fractures by evaluating treatment effects in ‘real-world’ patients treated in different level 1 trauma centers by means of a propensity score matched analysis.
Study objective
The aim of this large multicentre prospective cohort study is to compare rib fixation with nonoperative treatment of a flail chest and multiple rib fractures by evaluating treatment effects in ‘real-world’ patients treated in different level 1 trauma centers.
Study design
- hospital admission
- 6 weeks after discharge
- 1 year after discharge
Intervention
Rib fracture fixation for patients with a flail chest or multiple rib fractures
R.M. Houwert
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
088 755 5555
R.M. Houwert
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
088 755 5555
Inclusion criteria
All adult (over 18 years) patients presenting at the Emergency Department (ED) of the participating hospitals with a CT scan confirmed flail chest or multiple rib fractures after blunt thoracic trauma will be enrolled in the cohort.
Exclusion criteria
- Mentally impaired patients who are unable to fill in the EQ5D-5L questionnaire
- Non-traumatic rib fractures
- Rib fractures as a result of cardiopulmonary resuscitation
- Allergy for titanium
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6647 |
| NTR-old | NTR6833 |
| Other | METC : 17-544/C |