Driving Pressure in Trauma

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT03367442
Collaborator
(none)
50
1
48.3
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 22, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Duration of mechanical Ventilation [1 day]

    Duration of mechanical Ventilation

Secondary Outcome Measures

  1. During of SDRA [1 day]

    During of SDRA

  2. Length of stay in intensive care unit [1 day]

    Length of stay in intensive care unit

  3. Mortality [1 day]

    Mortality

  4. Pulmonary compliance [1 day]

    Pulmonary compliance

  5. Pulmonary stress and strain [1 day]

    Pulmonary stress and strain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uhmontpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Principal Investigator: Jonathan CHARBIT, MD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT03367442
Other Study ID Numbers:
  • RECHMPL17_0354
First Posted:
Dec 8, 2017
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022