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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03367442
Other study ID # RECHMPL17_0354
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 22, 2018
Est. completion date September 15, 2022

Study information

Verified date September 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 15, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of mechanical Ventilation Duration of mechanical Ventilation 1 day
Secondary During of SDRA During of SDRA 1 day
Secondary Length of stay in intensive care unit Length of stay in intensive care unit 1 day
Secondary Mortality Mortality 1 day
Secondary Pulmonary compliance Pulmonary compliance 1 day
Secondary Pulmonary stress and strain Pulmonary stress and strain 1 day
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