Mode of Ventilation During Critical Illness at Multiple Centers

NCT07313956 | Enrolling By Invitation DMC

• 2 other identifiers: 250596K23HL175246
• Study Type: interventional
• Target: 4,785
• Locations: 1 country
• Sites: 4

Brief Summary

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?

Conditions

Respiratory Failure; Mechanical Ventilation; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days in the first 28 days

  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 Outcomes (1)

• All-cause, 28-day, in-hospital mortality

  From enrollment to 28 days after enrollment

Other Outcomes (13)

• Severe acidemia (Safety Outcome)

  From enrollment to 28 days after enrollment

• Barotrauma (Safety Outcome)

  From enrollment to 28 days after enrollment

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

  From enrollment to 28 days after enrollment

Study Arms (3)

Adaptive Pressure Control Group

ACTIVE COMPARATOR

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

Pressure Control Group

ACTIVE COMPARATOR

During invasive mechanical ventilation in a study location, pressure control will be used as the mode for continuous mandatory ventilation.

Other: Pressure control

Volume Control Group

ACTIVE COMPARATOR

During invasive mechanical ventilation in a study location, volume control will be used as the mode for continuous mandatory ventilation.

Other: Volume control

Interventions

Volume control OTHER

Volume control mode for invasive mechanical ventilation

Volume Control Group

Pressure control OTHER

Pressure control mode for invasive mechanical ventilation

Pressure Control Group

Adaptive pressure control OTHER

Adaptive pressure control for invasive mechanical ventilation

Adaptive Pressure Control Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27109, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

• Rappaport SH, Shpiner R, Yoshihara G, Wright J, Chang P, Abraham E. Randomized, prospective trial of pressure-limited versus volume-controlled ventilation in severe respiratory failure. Crit Care Med. 1994 Jan;22(1):22-32. doi: 10.1097/00003246-199401000-00009.

  PMID: 8124968 BACKGROUND

• Esteban A, Alia I, Gordo F, de Pablo R, Suarez J, Gonzalez G, Blanco J. Prospective randomized trial comparing pressure-controlled ventilation and volume-controlled ventilation in ARDS. For the Spanish Lung Failure Collaborative Group. Chest. 2000 Jun;117(6):1690-6. doi: 10.1378/chest.117.6.1690.

  PMID: 10858404 BACKGROUND

• Rittayamai N, Katsios CM, Beloncle F, Friedrich JO, Mancebo J, Brochard L. Pressure-Controlled vs Volume-Controlled Ventilation in Acute Respiratory Failure: A Physiology-Based Narrative and Systematic Review. Chest. 2015 Aug;148(2):340-355. doi: 10.1378/chest.14-3169.

  PMID: 25927671 BACKGROUND

• Chatburn RL, El-Khatib M, Mireles-Cabodevila E. A taxonomy for mechanical ventilation: 10 fundamental maxims. Respir Care. 2014 Nov;59(11):1747-63. doi: 10.4187/respcare.03057. Epub 2014 Aug 12.

  PMID: 25118309 BACKGROUND

• Telias I, Madorno M, Pham T, Coudroy R, Mellado Artigas R, Baedorf-Kassis E, Chen CW, Spadaro S, Chiumello D, Beitler J, Kondili E, Tiribelli N, Fredes S, Becher T, Dres M, Liu K, Terzi N, Guerin C, Mauri T, Roca O, Mancebo J, Rodriguez N, Arnal JM, Goligher EC, Diehl JL, Jochmans S, Beloncle F, Rittayamai N, Mojoli F, Heunks L, de Vries H, Zhou JX, Guervilly C, Brochard L. Physiological Consequences of Breathing Effort According to the Mode of Ventilation During Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2025 Jul 23. doi: 10.1164/rccm.202411-2155OC. Online ahead of print.

  PMID: 40700741 BACKGROUND

• Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Muhs AL, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan TL, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, DeCoursey BR, Marvi TK, DeMasi SC, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD; Pragmatic Critical Care Research Group. Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial. Chest. 2025 Oct;168(4):912-923. doi: 10.1016/j.chest.2025.03.024. Epub 2025 Apr 4.

  PMID: 40189043 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Observer bias will be minimized by use of objective endpoints collected in duplicate by \[1\] study personnel and \[2\] automated data extraction from the electronic health record.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: In the MODEM trial, the entire study ICU will be assigned to a single ventilator mode (cluster-randomized) and the ICU will switch between volume control, pressure control, and adaptive pressure control modes every two months in a randomly generated sequence (cluster-crossover). Enrolled patients will be assigned to only one group at the time of their enrollment.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (4)