Stress Index to Individualize Mechanical Ventilation in ARDS

Vanderbilt University

Status: Terminated

Conditions: Acute Respiratory Distress Syndrome

Treatments: Procedure: Recruitment Maneuver with PEEP and Tidal Volume Optimization

Study type: Interventional

Funder types: Other

Identifiers

NCT02871102

160770

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• Inability to obtain surrogate consent

• Presence of specified comorbidities:

  1. pregnancy
  2. pre-existing severe chronic obstructive pulmonary disease, defined as FEV1 documented < 1L or baseline hypercapnia
  3. cerebral edema
  4. known intra-cranial abnormality
  5. 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Intervention Arm

Experimental group

Treatment:

Procedure: Recruitment Maneuver with PEEP and Tidal Volume Optimization