Condition category
Respiratory
Date applied
27/09/2015
Date assigned
28/10/2015
Last edited
21/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/02/2013

Overall trial end date

01/01/2016

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

www.lul.se

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

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27095122

Publication citations

Additional files

Editorial Notes

20/04/2016: Publication reference added.