NCT04778228

Driving Pressure as a Predictor of Mortality in Acute Respiratory Distress Syndrome Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to make analysis of potentially modifiable factors contributing to outcome of mechanically ventilated ARDS adult patient receiving lung protective strategy. Primary Objective: is to evaluate whether DP was superior to the variables that define it in predicting hospital outcome including mortality. Secondary Objective: is to identify manageable factors associated with outcome such as ventilator-related parameters and to investigate the role of non-modifiable factors such as demographic characteristics, severity of illness.

Detailed description

The acute respiratory distress syndrome (ARDS) is an acute and intense inflammatory disease process of the Lungs, characterized clinically by severe hypoxemia and bilateral pulmonary infiltrates. The hospital mortality ranges between 35% and 45% (1). Traditionally, critically ill patients requiring mechanical ventilation (MV) were ventilated using high tidal volumes (Vt) and high airway pressures, until the pivotal ARDS net randomized controlled trial (RCT) demonstrated that a "lung-protective" MV strategy using a Vt of 4-8 mL/kg predicted body weight (PBW) and moderate levels of positive end-expiratory pressure (PEEP) improved survival (2). The driving pressure (DP) (calculated as the Pplat minus applied PEEP) has been suggested as a major determinant for the beneficial effects of the three main components of lung-protective MV, namely, Vt, Pplat, and PEEP. and also a given DP would have different effects on outcome depending on the Vt, Pplat, and PEEP (3). A retrospective analysis of several trials in patients with ARDS comparing different PEEP levels at the same VT or different VT levels at the same PEEP, or a combination of both, found that ΔPrs is the stronger predictor of mortality as compared with Pplats (3).

Conditions

• ARDS

Interventions

Type	Name	Description
DEVICE	mechanical ventilation	critically ill patients requiring mechanical ventilation (MV) were ventilated using high tidal volumes (Vt) and high airway pressures, until the pivotal ARDS net randomized controlled trial (RCT) demonstrated that a "lung-protective" MV strategy using a Vt of 4-8 mL/kg predicted body weight (PBW) and moderate levels of positive end-expiratory pressure (PEEP) improved survival (2). Since then, limitation of Vt to 4-8 mL/kg PBW, plateau pressures (Pplat) to a maximum of 30 cm H2O, and application of PEEP 10 -16 cm H2O represent the standard for MV in ARDS patients.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-09-01
• Completion: 2023-01-01
• First posted: 2021-03-03
• Last updated: 2021-03-03

Locations

1 site across 1 country: Egypt