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Stress Index to Individualize Mechanical Ventilation in ARDS

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recruitment Maneuver with PEEP and Tidal Volume Optimization
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome focused on measuring mechanical ventilation, respiratory mechanics, acute respiratory distress syndrome, positive end-expiratory pressure, tidal volume

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

Outcomes

Primary Outcome Measures

Comparison of ARDSnet-optimized and protocol-optimized tidal volume
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
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 Outcome Measures

Comparison of ARDSnet-optimized and protocol-optimized PEEP
Mean absolute difference between safest PEEP as determined by experimental protocol with tidal volume of 6 mL/kg PBW (defined as the PEEP at which 6 mL/kg PBW yields the lowest driving pressure with a SI <1.05) versus the PEEP established by ARDSnet table.
Comparison of ARDSnet-optimized and protocol-optimized elastance
Mean difference in elastance prescribed by ARDSnet settings versus at lowest measured possible elastance achieving equivalent minute ventilation as ARDSnet table with respiratory rate < or = 35 per minute.

Full Information

First Posted
August 10, 2016
Last Updated
June 5, 2018
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02871102
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
The ART Trial was published suggesting harm by the intervention protocol, which was closely related to the protocol in this study, so the study was terminated.
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
mechanical ventilation, respiratory mechanics, acute respiratory distress syndrome, positive end-expiratory pressure, tidal volume

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Recruitment Maneuver with PEEP and Tidal Volume Optimization
Intervention Description
A staircase recruitment maneuver will be performed on pressure control ventilation followed by a decremental PEEP trial. During the decremental PEEP trial inspiratory tidal volumes will be varied at each step between 3 ml/kg and 10 ml/kg predicted body weight while recording the continuous pressure and flow tracings from the mechanical ventilator. With each PEEP and tidal volume combination, end expiratory and end-inspiratory plateau pressure and stress index will be assessed. At the completion of the decremental PEEP trial, the patient will be returned to ARDSnet-recommended ventilator settings.
Primary Outcome Measure Information:
Title
Comparison of ARDSnet-optimized and protocol-optimized tidal volume
Description
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.
Time Frame
Completion of the study intervention, less than 1 day
Title
Comparison of ARDSnet-optimized and protocol-optimized driving pressure
Description
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.
Time Frame
Completion of the study intervention, less than 1 day
Secondary Outcome Measure Information:
Title
Comparison of ARDSnet-optimized and protocol-optimized PEEP
Description
Mean absolute difference between safest PEEP as determined by experimental protocol with tidal volume of 6 mL/kg PBW (defined as the PEEP at which 6 mL/kg PBW yields the lowest driving pressure with a SI <1.05) versus the PEEP established by ARDSnet table.
Time Frame
Completion of the study intervention, less than 1 day
Title
Comparison of ARDSnet-optimized and protocol-optimized elastance
Description
Mean difference in elastance prescribed by ARDSnet settings versus at lowest measured possible elastance achieving equivalent minute ventilation as ARDSnet table with respiratory rate < or = 35 per minute.
Time Frame
Completion of the study intervention, less than 1 day
Other Pre-specified Outcome Measures:
Title
ICU-free days to 14 days after enrollment
Description
Comparison of ICU-free days to 14 days after enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.
Time Frame
14 days post-enrollment
Title
Ventilator-free days to 14 days after enrollment
Description
Comparison of ventilator-free days to 14 days after enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.
Time Frame
14 days post-enrollment
Title
ICU mortality at 28 days
Description
Comparison of 28-day ICU mortality post-enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.
Time Frame
28 days post-enrollment
Title
In-hospital mortality at 28 days
Description
Comparison of 28-day in-hospital mortality post-enrollment between groups of those patients who are ventilated with settings that coincide with those determined to be most protective by the experimental protocol (within 0.5 cc/kg PBW tidal volume and 1 cmH2O of PEEP) versus those not.
Time Frame
28 days post-enrollment
Title
Time-varying elastance
Description
Assessment of the stability of a model-imputed estimate of time-varying elastance for a given insufflation volume independent of total tidal volume per breath.
Time Frame
Completion of the study intervention, less than 1 day
Title
Comparison of ARDSnet-optimized and time-varying elastance-optimized tidal volume
Description
Mean absolute difference between tidal volume in cc/kg PBW prescribed by ARDSnet settings on ARDSnet PEEP versus maximal protective tidal volume defined by the point of rise of model-imputed time-varying elastance at ARDSnet PEEP on experimental protocol.
Time Frame
Completion of the study intervention, less than 1 day
Title
Comparison of ARDSnet-optimized and time-varying elastance-optimized driving pressure
Description
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 time-varying elastance not rising.
Time Frame
Completion of the study intervention, less than 1 day
Title
Comparison of ARDSnet-optimized and time-varying elastance-optimized PEEP
Description
Mean absolute difference between safest PEEP as determined by experimental protocol with tidal volume of 6 mL/kg PBW (defined as the PEEP at which 6 mL/kg PBW yields the lowest driving pressure without a rising time-varying elastance) versus the PEEP established by ARDSnet table.
Time Frame
Completion of the study intervention, less than 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29720277
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.
Results Reference
derived

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Stress Index to Individualize Mechanical Ventilation in ARDS

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