NCT03367442

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

November 22, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

December 4, 2017

Last Update Submit

September 27, 2022

Conditions

Keywords

Thoracic traumamechanical ventilationAcute respiratory distress syndromeEsophageal pressurePleural pressure

Outcome Measures

Primary Outcomes (1)

  • Duration of mechanical Ventilation

    Duration of mechanical Ventilation

    1 day

Secondary Outcomes (5)

  • During of SDRA

    1 day

  • Length of stay in intensive care unit

    1 day

  • Mortality

    1 day

  • Pulmonary compliance

    1 day

  • Pulmonary stress and strain

    1 day

Interventions

no intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with sever chest trauma under mechanical ventilation

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jonathan CHARBIT, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 8, 2017

Study Start

November 22, 2018

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations