Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure
NCT ID: NCT07294768
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2023-10-11
2024-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Standard of Care
Patients randomized to the standard of care group will continue to receive ventilator management per the ARDSnet-based protocol
Standard of Care
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.
VentCoach
Patients randomized to the VentCoach group, in addition to the standard of care, will also receive intermittent ventilator setting adjustments per the VentCoach protocol
VentCoach
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
Standard of Care
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.
Interventions
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VentCoach
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
Standard of Care
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.
Eligibility Criteria
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Inclusion Criteria
* Patients requiring intubation and mechanical ventilation for more than 24 hours.
* VentCoach protocol is specific to volume controlled continuous mandatory ventilation (S-CMV).
* Patient who are admitted to RMH 10-3/10-4 and MB 6BGF ICUs.
* Age greater than or equal to 18 years.
* Patient's legal representative should be able to provide informed consent to the study. Any participant speaking any language will be offered participation.
Exclusion Criteria
* Intubation and mechanical ventilation due to drug overdose with expected extubation of less than 24 hours.
* Intubation and mechanical ventilation in the setting of cardiac arrest.
* Intubation and mechanical ventilation for a primary neurological etiology, e.g. increased intracranial pressure, tumor mass effect, ischemic/hemorrhagic stroke, status epilepticus, etc.
* Mechanical ventilation to be guided by esophageal balloon.
* Subject deprived of freedom, minor, subject under a legal protective measure.
* Change in end-of-life decision anticipated after enrollment (or estimated 6-month mortality rate of greater than 50%).
Note: prone positioning is not a contraindication for participation.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Gustavo A. Cortes Puentes
Principal Investigator
Principal Investigators
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Gustavo A. Cortes Puentes, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-004855
Identifier Type: -
Identifier Source: org_study_id