Clinical trial NCT02871102: Stress Index to Individualize Mechanical Ventilation in ARDS
Official title: Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: mechanical ventilation
respiratory mechanics
acute respiratory distress syndrome
positive end-expiratory pressure
tidal volume
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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:

  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

Primary outcomes:
measure: Comparison of ARDSnet-optimized and protocol-optimized tidal volume
timeFrame: Completion of the study intervention, less than 1 day
measure: Comparison of ARDSnet-optimized and protocol-optimized driving pressure
timeFrame: Completion of the study intervention, less than 1 day
Secondary outcomes:
measure: Comparison of ARDSnet-optimized and protocol-optimized PEEP
timeFrame: Completion of the study intervention, less than 1 day
measure: Comparison of ARDSnet-optimized and protocol-optimized elastance
timeFrame: Completion of the study intervention, less than 1 day
Other outcomes:
measure: ICU-free days to 14 days after enrollment
timeFrame: 14 days post-enrollment
measure: Ventilator-free days to 14 days after enrollment
timeFrame: 14 days post-enrollment
measure: ICU mortality at 28 days
timeFrame: 28 days post-enrollment
measure: In-hospital mortality at 28 days
timeFrame: 28 days post-enrollment
measure: Time-varying elastance
timeFrame: Completion of the study intervention, less than 1 day
measure: Comparison of ARDSnet-optimized and time-varying elastance-optimized tidal volume
timeFrame: Completion of the study intervention, less than 1 day
measure: Comparison of ARDSnet-optimized and time-varying elastance-optimized driving pressure
timeFrame: Completion of the study intervention, less than 1 day
measure: Comparison of ARDSnet-optimized and time-varying elastance-optimized PEEP
timeFrame: Completion of the study intervention, less than 1 day
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: McKown AC, Semler MW, Rice TW. Best PEEP trials are dependent on tidal volume. Crit Care. 2018 May 2;22(1):115. doi: 10.1186/s13054-018-2047-4.