Clinical trial NCT04778228: Driving Pressure as a Predictor of Mortality in Acute Respiratory Distress Syndrome Patients
Official title: Driving Pressure as a Predictor of Mortality in Acute Respiratory Distress Syndrome Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Keywords: Driving pressure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion criteria:

ARDS Patients: who are treated with lung-protective MV and assessed on standardized ventilatory settings(4) at 24 hours after ARDS onset . All patients will meet the American-European Consensus Conference criteria for ARDS (5) on PEEP greater than or equal to 5 cm H2O and Berlin criteria for moderate or severe ARDS (6).

Exclusion criteria:

* Patients with left atrial hypertension, as diagnosed by the attending physician, as the primary cause of respiratory failure.
* Anticipated duration of mechanical ventilation of less than 48 hours.
* Severe chronic respiratory disease; neuromuscular disease that would prolong mechanical ventilation.
* Intracranial hypertension; morbid obesity; pregnancy.

Brief 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).

Eligibility criteria: Inclusion Criteria:

* ARDS Patients: who are treated with lung-protective MV and assessed on standardized ventilatory settings(4) at 24 hours after ARDS onset . All patients will meet the American-European Consensus Conference criteria for ARDS (5) on PEEP greater than or equal to 5 cm H2O and Berlin criteria for moderate or severe ARDS (6).

Exclusion Criteria:

* Patients with left atrial hypertension, as diagnosed by the attending physician, as the primary cause of respiratory failure.
* Anticipated duration of mechanical ventilation of less than 48 hours.
* Severe chronic respiratory disease; neuromuscular disease that would prolong mechanical ventilation.
* Intracranial hypertension; morbid obesity; pregnancy.

Primary outcomes:
measure: driving pressure
timeFrame: during intubation UP TO 28 days
Secondary outcomes:
measure: ventilator free days and hospital stay.
timeFrame: 28 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References: