- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02871102
Stress Index to Individualize Mechanical Ventilation in ARDS
June 5, 2018 updated by: Andrew McKown, Vanderbilt University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Completion of the study intervention, less than 1 day
|
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.
|
Completion of the study intervention, less than 1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of ARDSnet-optimized and protocol-optimized PEEP
Time Frame: Completion of the study intervention, less than 1 day
|
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.
|
Completion of the study intervention, less than 1 day
|
Comparison of ARDSnet-optimized and protocol-optimized elastance
Time Frame: Completion of the study intervention, less than 1 day
|
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.
|
Completion of the study intervention, less than 1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU-free days to 14 days after enrollment
Time Frame: 14 days post-enrollment
|
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.
|
14 days post-enrollment
|
Ventilator-free days to 14 days after enrollment
Time Frame: 14 days post-enrollment
|
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.
|
14 days post-enrollment
|
ICU mortality at 28 days
Time Frame: 28 days post-enrollment
|
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.
|
28 days post-enrollment
|
In-hospital mortality at 28 days
Time Frame: 28 days post-enrollment
|
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.
|
28 days post-enrollment
|
Time-varying elastance
Time Frame: Completion of the study intervention, less than 1 day
|
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.
|
Completion of the study intervention, less than 1 day
|
Comparison of ARDSnet-optimized and time-varying elastance-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 the point of rise of model-imputed time-varying elastance at ARDSnet PEEP on experimental protocol.
|
Completion of the study intervention, less than 1 day
|
Comparison of ARDSnet-optimized and time-varying elastance-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 time-varying elastance not rising.
|
Completion of the study intervention, less than 1 day
|
Comparison of ARDSnet-optimized and time-varying elastance-optimized PEEP
Time Frame: Completion of the study intervention, less than 1 day
|
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.
|
Completion of the study intervention, less than 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 10, 2016
First Submitted That Met QC Criteria
August 12, 2016
First Posted (Estimate)
August 18, 2016
Study Record Updates
Last Update Posted (Actual)
June 7, 2018
Last Update Submitted That Met QC Criteria
June 5, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 160770
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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