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

NCT ID: NCT04778228

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-01-01

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).

Conditions

ARDS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

protective lung strategy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shahenda Mohamed gamal eldin mohamed ali

principle investigator (assistant lecturer at Assiut university)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

shahenda mohamed gamal

Role: CONTACT

elkadyshahenda@aun.edu.eg

01009190918

maha kamel ghanem

Role: CONTACT

mahaghanem@hotmail.com

01227694434

Other Identifiers

driving pressure in ARDS

Identifier Type: -

Identifier Source: org_study_id