Driving Pressure in Trauma

Mechanical Ventilation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367442
• Other study ID #: RECHMPL17_0354
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Sever Chest Trauma
• Thoracic Injuries
• Wounds and Injuries

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