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Enrolling by Invitation

NCT Number: NCT07313956

Mode of Ventilation During Critical Illness at Multiple Centers

The goal of this clinical trial is to learn whether the choice of ventilator mode for patients on breathing machines in the intensive care unit affects their survival and recovery. To do this, researchers will assign the entire participating intensive care unit to one of the three available ventilator modes, alternating which mode is assigned in random sequence every 2 months. The main question it aims to answer is: Does the choice between volume control, pressure control, and adaptive pressure control affect the number of days that patients are alive and free of the breathing machine?

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Key information

Conditions

Respiratory Failure Critical Illness Disease Attributes Mechanical Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms 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

Rush University Medical Center, Chicago, Illinois, United States

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About this study

The MODEM trial is a cluster-randomized, cluster-crossover clinical trial comparing the effectiveness of three ventilator modes (volume control vs pressure control vs adaptive pressure control) for mechanical ventilation of critically ill adults at multiple centers. A total of 4,785 critically ill adults receiving invasive mechanical ventilation in intensive care units will be enrolled and included in the primary analysis. Each study unit will be assigned to a ventilator mode and will switch between modes every 2 months in an order determined by randomization. Enrolled patients will be assigned to receive volume control, pressure control, or adaptive pressure control according to the mode assigned to the unit at the time they were enrolled. The primary outcome will be ventilator-free days in the first 28 days, and the secondary outcome will be all-cause, 28-day in-hospital mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is receiving mechanical ventilation through an endotracheal tube or tracheostomy
  • Patient is physically located in a participating adult ICU

Exclusion criteria

  • Patient is known to be less than 18 years old
  • Patient is known to be a prisoner
  • Patient is known to have been receiving invasive mechanical ventilation at place of residence prior to hospital admission
  • Patient is receiving extracorporeal membrane oxygenation at the time when inclusion criteria are first met

Treatment and study plan

Volume Control

Other

Volume control mode for invasive mechanical ventilation

Pressure control

Other

Pressure control mode for invasive mechanical ventilation

Adaptive pressure control

Other

Adaptive pressure control for invasive mechanical ventilation

Primary outcomes

  1. Ventilator-free days in the first 28 days

    Time frame: From enrollment to 28 days after enrollment

    The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation. Receipt of invasive mechanical ventilation will be considered to end when patients undergo the final tracheal extubation or disconnection of the ventilator from a tracheostomy tube between enrollment and day 28.

Secondary outcomes

  1. All-cause, 28-day, in-hospital mortality

    Time frame: From enrollment to 28 days after enrollment

    All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment with outcome ascertainment ending at hospital discharge.

Other outcomes

  1. Severe acidemia (Safety Outcome)

    Time frame: From enrollment to 28 days after enrollment

    pH <7.1 on blood gas laboratory test

  2. Barotrauma (Safety Outcome)

    Time frame: From enrollment to 28 days after enrollment

    Pneumothorax or pneumomediastinum

  3. Receipt of invasive procedure for treatment of pneumothorax or pneumomediastinum (Safety Outcome)

    Time frame: From enrollment to 28 days after enrollment

    E.g., thoracostomy tube

  4. Shock (Safety Outcome)

    Time frame: From enrollment to 28 days after enrollment

    Receipt of continuous infusion of vasopressor or inotrope medications

  5. Exhaled tidal volume (Exploratory Intermediary Outcome)

    Time frame: From enrollment to 28 days after enrollment

    Measured in mL/kg of predicted body weight

  6. Exhaled tidal volumes above target range (Exploratory Intermediary Outcome)

    Time frame: From enrollment to 28 days after enrollment

    Proportion of recorded breaths with exhaled tidal volume values above the target range (>8 mL/kg predicted body weight)

  7. Peak inspiratory pressure (Exploratory Intermediary Outcome)

    Time frame: From enrollment to 28 days after enrollment

    Measured in cmH2O

  8. Peak inspiratory pressure above target range (Exploratory Intermediary Outcome)

    Time frame: From enrollment to 28 days after enrollment

    Proportion of recorded breaths with peak inspiratory values above the target range (>30cmH2O)

  9. Richmond Agitation-Sedation Scale (RASS) (Exploratory Intermediary Outcome)

    Time frame: From enrollment to 28 days after enrollment

    RASS is a 10 point scale of agitation or sedation ranging from -5 (most sedated, comatose) to +4 (most agitated, combative).

  10. Deep sedation (Exploratory Intermediary Outcome)

    Time frame: From enrollment to 28 days after enrollment

    Proportion of assessments with RASS of -4 or -5

  11. Delirium and coma-free days in the first 28 days (Exploratory Clinical Outcome)

    Time frame: From enrollment to 28 days after enrollment

    The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of delirium or coma

  12. Intensive care unit-free days in the first 28 days (Exploratory Clinical Outcome)

    Time frame: From enrollment to 28 days after enrollment

    The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free from intensive care unit admission after the final transfer out of the intensive care unit

  13. Hospital free days in the first 28 days (Exploratory Clinical Outcome)

    Time frame: From enrollment to 28 days after enrollment

    The number of calendar days, between enrollment and 28 days after enrollment, on which the patient is alive and free from hospital admission

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: MODEM

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 2, 2026
Registry last updated
May 6, 2026

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

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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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