- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03367442
Driving Pressure in Trauma
September 27, 2022 updated by: University Hospital, Montpellier
Driving Pressure in Trauma. Morbi-mortality and Pulmonary Mechanics in Relation to Transpulmonary Driving Pressures in Patients With Chest Trauma. A Prospective Observational Study
Traumatic chest injuries are responsible for significant morbidity and the cause of trauma-related death in 20%-25% of cases.
Thoracic trauma can include multiple injuries, mainly osseous (ribs, sternal fractures, flail chest), pulmonary contusions or lacerations, pneumothoraces and pleural effusions, and sometimes involve wounds to the heart and vessels (aortic dissection, cardiac contusion) or diaphragm.
Following trauma, patients with thoracic injuries are at risk of developing acute respiratory distress syndrome (ARDS).
This worsening of respiratory function can lead to requirement for mechanical ventilation.
In addition, changes to gas exchange may also be generated or aggravated by mechanical ventilation as a result of barotrauma, biotrauma, or ventilation-associated pneumonia.
Many mechanical ventilation strategies have been tried in trauma patients in the last 30 years to determine the optimal method of maximizing gas exchange with minimal lung damage.
The driving pressure of the respiratory system has been shown to strongly correlate with mortality in a recent large retrospective ARDSnet study.
Respiratory system driving pressure [plateau pressure-positive end-expiratory pressure (PEEP)] does not account for variable chest wall compliance especially in cases of chest trauma.
Esophageal manometry can be utilized to determine transpulmonary driving pressure.
A recent study suggests that utilizing PEEP titration to target positive transpulmonary pressure via esophageal manometry causes both improved elastance and driving pressures.
Treatment strategies leading to decreased respiratory system and transpulmonary driving pressure at 24 h may be associated with improved 28 day mortality.
However, currently no specific study with chest trauma patients exists.
We propose to investigate the effect of hight transpulmonary driving pressure on duration on mechanical ventilation, length of stay and mortality in patients with sever chest trauma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with sever chest trauma under mechanical ventilation
Description
Inclusion Criteria:
- Major patients (18-90 years old)
- Affiliated to the social security
- Hospitalized following severe trauma chest trauma
- Mechanical ventilatory support for a minimum of 72 hours
Exclusion criteria:
- Minor patients,
- Patients under tutorship / curatorship,
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of mechanical Ventilation
Time Frame: 1 day
|
Duration of mechanical Ventilation
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay in intensive care unit
Time Frame: 1 day
|
Length of stay in intensive care unit
|
1 day
|
|
Mortality
Time Frame: 1 day
|
Mortality
|
1 day
|
|
During of SDRA
Time Frame: 1 day
|
During of SDRA
|
1 day
|
|
Pulmonary compliance
Time Frame: 1 day
|
Pulmonary compliance
|
1 day
|
|
Pulmonary stress and strain
Time Frame: 1 day
|
Pulmonary stress and strain
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan CHARBIT, MD, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2018
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
September 15, 2022
Study Registration Dates
First Submitted
December 4, 2017
First Submitted That Met QC Criteria
December 7, 2017
First Posted (Actual)
December 8, 2017
Study Record Updates
Last Update Posted (Actual)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 27, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL17_0354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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