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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recruitment Maneuver with PEEP and Tidal Volume Optimization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Completion of the study intervention, less than 1 day |
| 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. | Completion of the study intervention, less than 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Completion of the study intervention, less than 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| ICU-free days to 14 days after 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 |
Inclusion Criteria:
Exclusion Criteria:
Inability to obtain surrogate consent
Presence of specified comorbidities:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29720277 | Derived | 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. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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|
| 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. | Completion of the study intervention, less than 1 day |
| Ventilator-free days to 14 days after 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 | 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 | 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 | 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 | 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 | 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 | 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 |