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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04778228
Enrollment
55
Registered
2021-03-03
Start date
2021-03-01
Completion date
2023-01-01
Last updated
2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

Driving pressure

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).

Interventions

DEVICEmechanical 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
driving pressureduring intubation UP TO 28 daysmore than or less than 14 cmH2O

Secondary

MeasureTime frameDescription
ventilator free days and hospital stay.28 dayscorrelate the driving pressure level with the number of days free of ventilator and earlier hospital discharge

Countries

Egypt

Contacts

Primary Contactshahenda mohamed gamal
elkadyshahenda@aun.edu.eg01009190918
Backup Contactmaha kamel ghanem
mahaghanem@hotmail.com01227694434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026