Stress Index to Individualize Mechanical Ventilation in ARDS
| Status: | Terminated |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/9/2018 |
| Start Date: | August 2016 |
| End Date: | December 2017 |
Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Andrew C. McKown, MD
Phone: 615-835-4955
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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