Stress Index to Individualize Mechanical Ventilation in ARDS

Stopped early · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome

In brief

Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a means of lung protective ventilation, but the mechanism for its effectiveness is not yet clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP). Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible means to minimize ventilator-induced lung injury. This protocol aims to identify the range of safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and the stress index, a tool to recognize potential lung hyperinflation during mechanical ventilation.

Key facts

Study ID

NCT02871102

Run by

Vanderbilt University

People needed

4

Starts

2016-08-01

Expected to finish

2017-12-01

Last updated by the study team

2018-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to the Intensive Care Unit
• Receiving invasive mechanical ventilation via endotracheal or tracheostomy tube
• Presence of ARDS by Berlin Criteria (acute onset bilateral pulmonary infiltrates incompletely explained by left heart failure together with a PaO2/FiO2 of <300 or SpO2/FiO2 <315)

You may not qualify if…

• Inability to obtain surrogate consent
• Presence of specified comorbidities:
• pregnancy
• pre-existing severe chronic obstructive pulmonary disease, defined as FEV1 documented < 1L or baseline hypercapnia
• cerebral edema
• known intra-cranial abnormality
• acute coronary syndrome
• Endotracheal or tracheostomy cuff leak
• Chest tube with persistent air leak
• Severe hemodynamic instability (defined as attending judgment that the patient is unable to safely tolerate ventilator manipulations)
• Presence of spontaneous respiratory activity as evidenced by examination of the ventilator waveform tracing
• Intrinsic PEEP of > 5 cmH2O
• Assessment of study staff or patient's attending physician that the patient would not be a good study participant

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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