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Sever Chest TraumaNCT03367442

Driving Pressure in Trauma

An observational study of Sever Chest Trauma and Mechanical Ventilation, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Sever Chest Trauma, Mechanical Ventilation
How many people
50 participants
Where
1 siteFrance
Study dates
22 Nov 2018to 15 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with sever chest trauma under mechanical ventilation

Who may be able to join

  • 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

Who cannot join

  • Minor patients,
  • Patients under tutorship / curatorship,
  • Pregnant or lactating women

Trial locations and contacts

1 site in 1 country.

France1 site
  • Uhmontpellier

    Montpellier, 34295

Other trials in France

About this study

Official title: 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.

Being tested
no intervention
Keywords
Thoracic trauma, mechanical ventilation, Acute respiratory distress syndrome, Esophageal pressure, Pleural pressure
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of mechanical Ventilation

    Duration of mechanical Ventilation

    Measured: 1 day

Secondary outcomes (5)
  1. During of SDRA

    During of SDRA

    Measured: 1 day

  2. Length of stay in intensive care unit

    Length of stay in intensive care unit

    Measured: 1 day

  3. Mortality

    Mortality

    Measured: 1 day

  4. Pulmonary compliance

    Pulmonary compliance

    Measured: 1 day

  5. Pulmonary stress and strain

    Pulmonary stress and strain

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start22 Nov 2018
  3. Primary completion15 Sep 2022
  4. Study completion15 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367442
Sponsor's protocol ID
RECHMPL17_0354
Status last verified
Sep 2022
First submitted
4 Dec 2017
Last updated
28 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

An observational study of Sever Chest Trauma and Mechanical Ventilation, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of mechanical Ventilation (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.

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