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

NCT04778228 | Unknown

• 1 other identifier: driving pressure in ARDS
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS

Keywords

Driving pressure

Outcome Measures

Primary Outcomes (1)

• driving pressure

  more than or less than 14 cmH2O

  during intubation UP TO 28 days

Secondary Outcomes (1)

• ventilator free days and hospital stay.

  28 days

Interventions

mechanical ventilation DEVICE

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.

Also known as: protective lung strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Central Study Contacts

shahenda mohamed gamal

CONTACT

01009190918; elkadyshahenda@aun.edu.eg

maha kamel ghanem

CONTACT

01227694434; mahaghanem@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator (assistant lecturer at Assiut university)

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: March 3, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

EG (1)