Respiratory FailureMODEMNCT07313956
Mode of Ventilation During Critical Illness at Multiple Centers
A study of Respiratory Failure and Mechanical Ventilation, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation, Critical Illness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,785 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 May 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is receiving mechanical ventilation through an endotracheal tube or tracheostomy
- Patient is physically located in a participating adult ICU
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
The Johns Hopkins Hospital
Baltimore, Maryland, 21224
Rush University Medical Center
Chicago, Illinois, 60612
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27109
About this study
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?
Read the 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.
- Being tested
- Volume control, Pressure control, Adaptive pressure control
- Medical subject headings
- Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume controlOther
Volume control mode for invasive mechanical ventilation
Pressure controlOther
Pressure control mode for invasive mechanical ventilation
Adaptive pressure controlOther
Adaptive pressure control for invasive mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Volume control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 28 days after enrollment
Secondary outcomes (1)
All-cause, 28-day, in-hospital mortality
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.
Measured: From enrollment to 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 May 2026
- Primary completionJan 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 4,785 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kevin P Seitz, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313956
- Sponsor's protocol ID
- 250596
- Other IDs
- K23HL175246
- Acronym
- MODEM
- Status last verified
- May 2026
- First submitted
- 30 Dec 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 8124968Esteban 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.
PubMed 10858404Rittayamai 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.
PubMed 25927671Chatburn 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.
PubMed 25118309Telias 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; BEARDS and PLUG Investigators. Physiological Consequences of Breathing Effort According to the Mode of Ventilation during Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2026 Mar 1;212(3):487-499. doi: 10.1164/rccm.202411-2155OC.
PubMed 40700741Seitz 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.
PubMed 40189043
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mode of Ventilation During Critical Illness at Multiple Centers
- ClinicalTrials.gov ID
- NCT07313956
- Acronym / sponsor ID
- MODEM / 250596
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,785 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 May 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adaptive Pressure Control Group | Active comparator | Other: Adaptive pressure controlDuring invasive mechanical ventilation in a study location, adaptive pressure control will be used as the mode for continuous mandatory ventilation. |
| Pressure Control Group | Active comparator | Other: Pressure controlDuring invasive mechanical ventilation in a study location, pressure control will be used as the mode for continuous mandatory ventilation. |
| Volume Control Group | Active comparator | Other: Volume controlDuring invasive mechanical ventilation in a study location, volume control will be used as the mode for continuous mandatory ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is receiving mechanical ventilation through an endotracheal tube or tracheostomy
- Patient is physically located in a participating adult ICU
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume controlVolume control mode for invasive mechanical ventilation | Other | Volume Control Group |
| Pressure controlPressure control mode for invasive mechanical ventilation | Other | Pressure Control Group |
| Adaptive pressure controlAdaptive pressure control for invasive mechanical ventilation | Other | Adaptive Pressure Control Group |
Primary outcome
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.
1 secondary outcome
All-cause, 28-day, in-hospital mortality
Time frame: From enrollment to 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 8124968Rappaport 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.
- Background: PubMed 10858404Esteban 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.
- Background: PubMed 25927671Rittayamai 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.
- Background: PubMed 25118309Chatburn 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.
- Background: PubMed 40700741Telias 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; BEARDS and PLUG Investigators. Physiological Consequences of Breathing Effort According to the Mode of Ventilation during Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2026 Mar 1;212(3):487-499. doi: 10.1164/rccm.202411-2155OC.
- Background: PubMed 40189043Seitz 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.
- Individual participant dataSharing planned: Yes
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Respiratory Failure and Mechanical Ventilation, run by Vanderbilt University Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days in the first 28 days (time frame: From enrollment to 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07313956, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.