Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure

Mayo Clinic

Status: Completed

Conditions: Mechanical Ventilation

Treatments: Other: Standard of Care; Other: VentCoach

Study type: Interventional

Funder types: Other

Identifiers

NCT07294768

23-004855

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute hypoxemic and/or hypercapnic respiratory failure.
• 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 for airway protection in the setting of procedures/surgeries, e.g. interventional radiology, surgery, or endoscopy.
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Patients randomized to the standard of care group will continue to receive ventilator management per the ARDSnet-based protocol

Treatment:

Other: Standard of Care

VentCoach

Experimental group

Description:

Patients randomized to the VentCoach group, in addition to the standard of care, will also receive intermittent ventilator setting adjustments per the VentCoach protocol

Treatment:

Other: Standard of Care

Other: VentCoach