Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Respiratory Distress Syndrome
- Sponsor
- Vanderbilt University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Comparison of ARDSnet-optimized and protocol-optimized tidal volume
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Andrew McKown
Fellow in Pulmonary and Critical Care Medicine
Vanderbilt University
Eligibility Criteria
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:
- •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
Outcomes
Primary Outcomes
Comparison of ARDSnet-optimized and protocol-optimized tidal volume
Time Frame: Completion of the study intervention, less than 1 day
Mean absolute difference between tidal volume in cc/kg PBW prescribed by ARDSnet settings on ARDSnet PEEP versus maximal protective tidal volume defined by stress index \<1.05 at the ARDSnet PEEP on experimental protocol.
Comparison of ARDSnet-optimized and protocol-optimized driving pressure
Time Frame: Completion of the study intervention, less than 1 day
Mean difference in driving pressure prescribed by ARDSnet settings versus at lowest measured possible driving pressure that achieves equivalent minute ventilation as ARDSnet table with respiratory rate \< or = 35 per minute and SI \<1.05.
Secondary Outcomes
- Comparison of ARDSnet-optimized and protocol-optimized PEEP(Completion of the study intervention, less than 1 day)
- Comparison of ARDSnet-optimized and protocol-optimized elastance(Completion of the study intervention, less than 1 day)