Mode of Ventilation During Critical Illness at Multiple Centers (MODEM)

May 4, 2026 updated by: Kevin P Seitz, Vanderbilt University Medical Center
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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

4785

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • The Johns Hopkins Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27109
        • Wake Forest University Health Sciences
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adaptive Pressure Control Group
During invasive mechanical ventilation in a study location, adaptive pressure control will be used as the mode for continuous mandatory ventilation.
Other: Adaptive pressure control
Adaptive pressure control for invasive mechanical ventilation
Active Comparator: Pressure Control Group
During invasive mechanical ventilation in a study location, pressure control will be used as the mode for continuous mandatory ventilation.
Other: Pressure control
Pressure control mode for invasive mechanical ventilation
Active Comparator: Volume Control Group
During invasive mechanical ventilation in a study location, volume control will be used as the mode for continuous mandatory ventilation.
Other: Volume control
Volume control mode for invasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 28 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 28 days after enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe acidemia (Safety Outcome)
Time Frame: From enrollment to 28 days after enrollment
pH <7.1 on blood gas laboratory test
From enrollment to 28 days after enrollment
Barotrauma (Safety Outcome)
Time Frame: From enrollment to 28 days after enrollment
Pneumothorax or pneumomediastinum
From enrollment to 28 days after enrollment
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
From enrollment to 28 days after enrollment
Shock (Safety Outcome)
Time Frame: From enrollment to 28 days after enrollment
Receipt of continuous infusion of vasopressor or inotrope medications
From enrollment to 28 days after enrollment
Exhaled tidal volume (Exploratory Intermediary Outcome)
Time Frame: From enrollment to 28 days after enrollment
Measured in mL/kg of predicted body weight
From enrollment to 28 days after enrollment
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)
From enrollment to 28 days after enrollment
Peak inspiratory pressure (Exploratory Intermediary Outcome)
Time Frame: From enrollment to 28 days after enrollment
Measured in cmH2O
From enrollment to 28 days after enrollment
Deep sedation (Exploratory Intermediary Outcome)
Time Frame: From enrollment to 28 days after enrollment
Proportion of assessments with RASS of -4 or -5
From enrollment to 28 days after enrollment
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
From enrollment to 28 days after enrollment
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
From enrollment to 28 days after enrollment
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
From enrollment to 28 days after enrollment
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)
From enrollment to 28 days after enrollment
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).
From enrollment to 28 days after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250596
  • K23HL175246 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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