Lung complications after traumatic pelvic fracture in intensive care patients
| ISRCTN | ISRCTN10335587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10335587 |
| Protocol serial number | N/A |
| Sponsor | Uppsala County Council (Sweden) |
| Funder | Uppsala County Council |
- Submission date
- 27/09/2015
- Registration date
- 28/10/2015
- Last edited
- 21/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
The pelvis is a butterfly-shaped fused ring of bones which sit at the bottom of the spine. Fractures of the pelvis are most commonly caused by serious injuries (major trauma), such as in a car accident or fall from a great height. When a person sustains major physical trauma, direct or indirect complications often arise. Acute respiratory distress syndrome (ARDS) is a life-threatening condition, where the lungs are unable to provide the body with adequate oxygen to meet its’ requirements. This condition is one of the most common lung complications when a person is already critically ill or seriously injured. The aim of this study is to find out how common lung complications such as ARDS are in people who have a traumatic pelvic fracture.
Who can participate?
Adults admitted to an intensive care unit (ICU) at Uppsala University Hospital with a fractured pelvis between 2007 and 2014.
What does the study involve?
Records of patients are accessed from the publically available pelvic fracture database. The researchers then record the amount of these patients who suffered any lung complications during their stay in intensive care.
What are the possible benefits and risks of participating?
There are no potential benefits or risks of participating in this study.
Where is the study run from?
Department of Anesthesiology and Intensive Care Medicine, Uppsala Academic Hospital (Sweden)
When is the study starting and how long is it expected to run for?
February 2013 to January 2016
Who is funding the study?
Uppsala County Council (Sweden)
Who is the main contact?
Mr Joakim Engström
Contact information
Scientific
Department of Anesthesiology and Intensive Care Medicine
Uppsala University
Akademiska sjukhuset
ANIVA Ing70, 1 tr
Uppsala
75185
Sweden
 ORCID ID |
0000-0001-6100-189X |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Pulmonary complications after pelvic fracture in critically ill patients |
| Study objectives | The aim of the study is to investigate the hypothesis with the primary end-point of lung complication rate in all patients that has been admitted to an ICU at Uppsala University Hospital between 2007 and 2014 due to pelvic fracture. |
| Ethics approval(s) | Regional Ethical Review Board, Uppsala (Regionala etikprövningsnämnden, Uppsala), 09/08/2006, ref: 2006/140 |
| Health condition(s) or problem(s) studied | Lung complications after traumatic pelvic fracture |
| Intervention | From the pelvic fracture database, data from patient who have been admitted to one of the ICUs at Uppsala University Hospital between 2007 and 2014 is collected. Data that will be extracted is: date of injury, type of pelvic fracture, SAPS3, EMR, comorbidity, other injurys, origin of trauma, ISS, AIS, time to surgery, blood loss during surgery, ICU stay in days, ventilatory support, time in ventilatory support, p/F-ratio, pulmonary radiology, complication rate, vasoactive drugs, duration of need of vasoactive drugs, laboratory data, morbidity and mortality. |
| Intervention type | Other |
| Primary outcome measure(s) |
Acute respiratory distress syndrome (ARDS) frequency will be recorded from information in the pelvic fracture database during the intensive care period after the injury occurs. |
| Key secondary outcome measure(s) |
Frequency of other lung complications (pneumonia, pneumothorax and pulmonary embolism) will be recorded from information in the pelvic fracture database during the intensive care period after the injury occurs. |
| Completion date | 01/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Aged 18 or over 2. Patients admitted to any of the ICUs at Uppsala University Hospital after traumatic pelvic fracture between 2007-2014 |
| Key exclusion criteria | 1. Patients without an informed consent 2. Pregnancy 3. Patients not admitted to an ICU during hospital stay |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
ANIVA Ing70, 1 tr
Uppsala
75185
Sweden
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? |
|---|---|---|---|---|---|
| Results article | results | 19/04/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/04/2016: Publication reference added.
