Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Mr Joakim Engström
ORCID ID
http://orcid.org/0000-0001-6100-189X
Contact details
Department of Anesthesiology and Intensive Care Medicine
Uppsala University
Akademiska sjukhuset
ANIVA Ing70
1 tr
Uppsala
75185
Sweden
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pulmonary complications after pelvic fracture in critically ill patients
Acronym
Study hypothesis
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
Study design
Single-centre cohort study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
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.
Secondary outcome measures
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.
Overall study start date
01/02/2013
Overall study end date
01/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
100-200 patients
Participant exclusion criteria
1. Patients without an informed consent
2. Pregnancy
3. Patients not admitted to an ICU during hospital stay
Recruitment start date
01/01/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Sweden
Study participating centre
Uppsala Academic Hospital
Department of Anesthesiology and Intensive Care Medicine
ANIVA Ing70, 1 tr
Uppsala
75185
Sweden
Sponsor information
Organisation
Uppsala County Council (Sweden)
Sponsor details
Slottsgränd 2
Uppsala
753 09
Sweden
Sponsor type
Government
Website
ROR
Funders
Funder type
Government
Funder name
Uppsala County Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plan to publish the study results in a major trauma journal.
Intention to publish date
01/06/2016
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 19/04/2016 | Yes | No |