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The purpose of this research is to evaluate a different way of using the mechanical ventilator device to help better protect the lungs while the patient recovers. We will compare VentCoach to the current standard mechanical ventilation techniques used in our Intensive Care Units.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Patients randomized to the standard of care group will continue to receive ventilator management per the ARDSnet-based protocol |
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| VentCoach | Experimental | Patients randomized to the VentCoach group, in addition to the standard of care, will also receive intermittent ventilator setting adjustments per the VentCoach protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VentCoach | Other | VentCoach, a mechanical power-guided lung protective ventilation protocol, will be used to set ventilator adjustments. VentCoach ventilator assessments and adjustments will be performed within one hour after enrollment, and then every 4 hours thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the VentCoach protocol | Total number of patients to achieve adherence will be defined as documented reduction in mechanical power (MP) or MP less than 12 J/min, in the 16 patients assigned to the VentCoach group | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to removal from ventilator | Time to successful extubation, allocation to ECMO, or death reported in number of days | 1 year |
| Incidence of patient-ventilator dyssynchrony | Number of patients to experience patient-ventilator dyssynchrony, defined as double triggering and flow starvation |
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Inclusion Criteria:
Exclusion Criteria:
Note: prone positioning is not a contraindication for participation.
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo A. Cortes Puentes, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41708744 | Derived | Zheng C, Abdulla SW, Bauer PR, Rocco PRM, Marini JJ, Oeckler RA, Cortes-Puentes GA. Mechanical power guided lung protective ventilation in acute respiratory failure using the VentCoach approach. Sci Rep. 2026 Feb 18;16(1):9786. doi: 10.1038/s41598-026-40389-7. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Intubated patients will be managed per the standard of care ARDSnet-based mechanical ventilation management at Mayo Clinic, with routine RT/MD assessments, and ventilator setting changes as necessary for the treatment of the patient. |
|
| 1 year |
| Overall use of sedation | Total use of analgesia, converted to morphine equivalent | 1 year |
| Overall use of paralytics | Total number of patients to require paralytics: bolus and infusion of neuromuscular blockade outside intubation procedure | 1 year |
| Oxygenation index | Oxygenation index is calculated by the following equation: mean airway pressure MAP (in cmH2O) × FiO2 × 100 ÷ PaO2 and is reported as a single number. | Baseline, end of treatment (up to 14 days) |