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Completed

NCT Number: NCT05563779

Mode Of Ventilation During Critical IllnEss Pilot Trial

Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Receiving mechanical ventilation through an endotracheal tube or tracheostomy
  • Admitted to the study ICU

Exclusion criteria

  • Patient is pregnant
  • Patient is a prisoner
  • Patient receiving invasive mechanical ventilation at place of residence prior to hospital admission
  • Patient receiving extracorporeal membrane oxygenation at the time of admission to the study ICU

Treatment and study plan

Volume Control mode

Other

Volume Control mode for mechanical ventilation

Pressure Control mode

Other

Pressure Control mode for mechanical ventilation

Adaptive Pressure Control mode

Other

Adaptive Pressure Control mode for mechanical ventilation

Primary outcomes

  1. Ventilator-free Days (VFDs) to Day 28 After Enrollment

    Time frame: Enrollment to 28 days

    Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.

Other outcomes

  1. Exposure to Assigned Study Mode in First 3 Days (Feasibility Outcome)

    Time frame: Enrollment to 72 hours

    Percentage of time in the assigned mode while receiving invasive mechanical ventilation in the study ICU between enrollment and 72 hours after enrollment.

  2. Adherence to Study Mode in First 3 Days (Feasibility Outcome)

    Time frame: Enrollment to 72 hours

    Percentage of time in the assigned mode while receiving invasive mechanical ventilation in the study ICU with a mandatory mode between enrollment and 72 hours after enrollment (excluding time spent in spontaneous modes).

  3. Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome)

    Time frame: Enrollment to 28 days

  4. Number of Patients With a "Mode Modification Sheet" Completed by Treating Clinicians (Feasibility Outcome)

    Time frame: Enrollment to 28 days

  5. Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Efficacy and Safety Outcome)

    Time frame: Enrollment to the first of extubation, 28 days, or death

  6. Percentage of Exhaled Tidal Volumes Above Target Range (Exploratory Efficacy and Safety Outcome)

    Time frame: Enrollment to the first of extubation, 28 days, or death

    Percentage of exhaled tidal volume values above target range (>8mL/kg predicted body weight), reported as a percentage.

  7. Hypoxemia During Mechanical Ventilation (Exploratory Safety and Efficacy Outcome)

    Time frame: Enrollment to the first of 28 days or death

    Hypoxemia during mechanical ventilation defined as an SpO2 <85% for more than 5 minutes

  8. Severe Acidemia During Mechanical Ventilation (Exploratory Safety and Efficacy Outcome)

    Time frame: Enrollment to 28 days

    Severe acidemia during mechanical ventilation: pH < 7.1 on blood gas

  9. Number of Blood Gas Laboratory Tests on the First Study Day (Exploratory Safety and Efficacy Outcome)

    Time frame: Enrollment to 1 day

  10. Pneumomediastinum or Pneumothorax During Mechanical Ventilation (Exploratory Efficacy and Safety Outcome)

    Time frame: Enrollment to 28 days

  11. SOFA Score on the First Study Day (Exploratory Safety and Efficacy Outcome)

    Time frame: Enrollment to 1 day

    The Sequential Organ Failure Assessment (SOFA) score is composed of scores from six organ systems, graded from 0 to 4 according to the degree of dysfunction or failure. Scores range from 0 (no evidence of organ dysfunction or failure) to 24 (evidence of severe organ dysfunction or failure). The mean of SOFA scores on study day 1 was calculated for each patient.

  12. Delirium and Coma Free Days to Day 28 (Exploratory Efficacy and Safety Outcome)

    Time frame: Enrollment to 28 days

    Number of days alive and without delirium or coma before 28 days to study day 28

  13. Intensive Care Unit-free Days to Study Day 28 (Exploratory Clinical Outcome)

    Time frame: Enrollment to 28 days

    Number of days alive and free from intensive care unit admission after the final transfer out of the intensive care unit before 28 days to study day 28

  14. Hospital-Free Days to Study Day 28 (Exploratory Clinical Outcome)

    Time frame: Enrollment to 28 days

    Number of days alive and free from hospitalization after the final transfer out of the hospital before 28 days to study day 28

  15. In-hospital Mortality to Study Day 28 (Exploratory Clinical Outcome)

    Time frame: Enrollment to 28 days

    All-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: MODE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2022
Registry last updated
Feb 23, 2026

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.

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