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

NCT07294768 | Completed

• 1 other identifier: 23-004855
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to removal from ventilator

  1 year

• Incidence of patient-ventilator dyssynchrony

  1 year

• Overall use of sedation

  1 year

• Overall use of paralytics

  1 year

• Oxygenation index

  Baseline, end of treatment (up to 14 days)

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

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

Other: VentCoach; Other: Standard of Care

Interventions

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

VentCoach

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.

Standard of Care; VentCoach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gustavo A. Cortes Puentes, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: October 11, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)