Skip to main content
OpenTrials
Completed

NCT Number: NCT07294768

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Adherence to the VentCoach protocol

    Time frame: 1 year

    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

Secondary outcomes

  1. Time to removal from ventilator

    Time frame: 1 year

    Time to successful extubation, allocation to ECMO, or death reported in number of days

  2. Incidence of patient-ventilator dyssynchrony

    Time frame: 1 year

    Number of patients to experience patient-ventilator dyssynchrony, defined as double triggering and flow starvation

  3. Overall use of sedation

    Time frame: 1 year

    Total use of analgesia, converted to morphine equivalent

  4. Overall use of paralytics

    Time frame: 1 year

    Total number of patients to require paralytics: bolus and infusion of neuromuscular blockade outside intubation procedure

  5. Oxygenation index

    Time frame: Baseline, end of treatment (up to 14 days)

    Oxygenation index is calculated by the following equation: mean airway pressure MAP (in cmH2O) × FiO2 × 100 ÷ PaO2 and is reported as a single number.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.