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

Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure: A Feasibility, Double Arm, Single-blinded Study

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Other: Standard of Care; Other: VentCoach

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Patients randomized to the standard of care group will continue to receive ventilator management per the ARDSnet-based protocol	Other: 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.
Experimental: 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	Other: 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.; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Gustavo A. Cortes Puentes, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): May 17, 2024

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 23-004855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No