Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:25 PM
Study NCT ID:
NCT07313956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mode of Ventilation During Critical Illness at Multiple Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4785}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-30', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Severe acidemia (Safety Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'pH \\<7.1 on blood gas laboratory test'}, {'measure': 'Barotrauma (Safety Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'Pneumothorax or pneumomediastinum'}, {'measure': 'Receipt of invasive procedure for treatment of pneumothorax or pneumomediastinum (Safety Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'E.g., thoracostomy tube'}, {'measure': 'Shock (Safety Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'Receipt of continuous infusion of vasopressor or inotrope medications'}, {'measure': 'Exhaled tidal volume (Exploratory Intermediary Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'Measured in mL/kg of predicted body weight'}, {'measure': 'Exhaled tidal volumes above target range (Exploratory Intermediary Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'Proportion of recorded breaths with exhaled tidal volume values above the target range (\\>8 mL/kg predicted body weight)'}, {'measure': 'Peak inspiratory pressure (Exploratory Intermediary Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'Measured in cmH2O'}, {'measure': 'Peak inspiratory pressures above target range (Exploratory Intermediary Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'Proportion of recorded breaths with peak inspiratory values above the target range (\\>30cmH2O)'}, {'measure': 'Richmond Agitation-Sedation Scale (RASS) (Exploratory Intermediary Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment'}, {'measure': 'Deep sedation (Exploratory Intermediary Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'Proportion of assessments with RASS of -4 or -5'}, {'measure': 'Delirium and coma-free days in the first 28 days (Exploratory Clinical Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of delirium or coma'}, {'measure': 'Intensive care unit-free days in the first 28 days (Exploratory Clinical Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': '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'}, {'measure': 'Hospital free days in the first 28 days (Exploratory Clinical Outcome)', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': 'The number of calendar days, between enrollment and 28 days after enrollment, on which the patient is alive and free from hospital admission'}], 'primaryOutcomes': [{'measure': 'Ventilator-free days in the first 28 days', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'All-cause, 28-day, in-hospital mortality', 'timeFrame': 'From enrollment to 28 days after enrollment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure', 'Mechanical Ventilation', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '8124968', 'type': 'BACKGROUND', 'citation': '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': '10858404', 'type': 'BACKGROUND', 'citation': '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': '25927671', 'type': 'BACKGROUND', 'citation': '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': '25118309', 'type': 'BACKGROUND', 'citation': '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': '40700741', 'type': 'BACKGROUND', 'citation': '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': '40189043', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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?', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is receiving mechanical ventilation through an endotracheal tube or tracheostomy\n* Patient is physically located in a participating adult ICU\n\nExclusion Criteria:\n\n* Patient is known to be less than 18 years old\n* Patient is known to be a prisoner\n* Patient is known to have been receiving invasive mechanical ventilation at place of residence prior to hospital admission\n* Patient is receiving extracorporeal membrane oxygenation at the time when inclusion criteria are first met'}, 'identificationModule': {'nctId': 'NCT07313956', 'acronym': 'MODEM', 'briefTitle': 'Mode of Ventilation During Critical Illness at Multiple Centers', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Mode of Ventilation During Critical Illness at Multiple Centers', 'orgStudyIdInfo': {'id': '250596'}, 'secondaryIdInfos': [{'id': 'K23HL175246', 'link': 'https://reporter.nih.gov/quickSearch/K23HL175246', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adaptive Pressure Control Group', 'description': 'During invasive mechanical ventilation in a study location, adaptive pressure control will be used as the mode for continuous mandatory ventilation.', 'interventionNames': ['Other: Adaptive pressure control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pressure Control Group', 'description': 'During invasive mechanical ventilation in a study location, pressure control will be used as the mode for continuous mandatory ventilation.', 'interventionNames': ['Other: Pressure control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Volume Control Group', 'description': 'During invasive mechanical ventilation in a study location, volume control will be used as the mode for continuous mandatory ventilation.', 'interventionNames': ['Other: Volume control']}], 'interventions': [{'name': 'Volume control', 'type': 'OTHER', 'description': 'Volume control mode for invasive mechanical ventilation', 'armGroupLabels': ['Volume Control Group']}, {'name': 'Pressure control', 'type': 'OTHER', 'description': 'Pressure control mode for invasive mechanical ventilation', 'armGroupLabels': ['Pressure Control Group']}, {'name': 'Adaptive pressure control', 'type': 'OTHER', 'description': 'Adaptive pressure control for invasive mechanical ventilation', 'armGroupLabels': ['Adaptive Pressure Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'contacts': [{'name': 'Kevin P Seitz, MD, MSc', 'role': 'CONTACT', 'email': 'kevin.seitz@vumc.org', 'phone': '615-936-9329'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Kevin P Seitz, MD, MSc', 'role': 'CONTACT', 'email': 'kevin.seitz@vumc.org', 'phone': '615-936-9329'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Kevin P Seitz', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}