Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06148467
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2023-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reverse Trigger Phenotypification and Response to Ventilatory Adjustments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2023-11-19', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of RT', 'timeFrame': '60 days', 'description': 'Total time of presence of RT'}, {'measure': 'Phenotypes of RT', 'timeFrame': '60 days', 'description': "Rate of the different phenotypes according to cycle initiation and termination of patient's respiratory effort"}, {'measure': 'Intensity of breathing efforts', 'timeFrame': '60 days', 'description': 'Intensity of respiratory efforts as measured by esophageal manometry'}, {'measure': 'Association with severity', 'timeFrame': '60 days', 'description': 'Association of RT with lung disease severity as measured by pO2:FiO2 ratio'}, {'measure': 'Response to ventilatory adjustments', 'timeFrame': '60 days', 'description': 'Change in RT characteristics after changing ventilatory settings'}], 'primaryOutcomes': [{'measure': 'Incidence of reverse trigger', 'timeFrame': '60 days', 'description': 'Proportion of patients who developed reverse trigger'}], 'secondaryOutcomes': [{'measure': 'Days of mechanical ventilation', 'timeFrame': '60 days', 'description': 'Days of mechanical ventilation'}, {'measure': 'ICU length of stay', 'timeFrame': '60 days', 'description': 'Days from ICU admission to discharge to wards'}, {'measure': 'Mortality', 'timeFrame': '60 days', 'description': 'Rate of deceased patients in percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reverse trigger', 'Acute Respiratory Distress Syndrome', 'Dyssynchony', 'Mechanical Ventilation'], 'conditions': ['Reverse Trigger', 'Acute Respiratory Distress Syndrome', 'Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective observational study is to describe the incidence of reverse trigger (RT) in mechanically ventilated patients with diagnosis of acute respiratory distress syndrome (ARDS).\n\nThe main questions it aims to answer are:\n\n* Real incidence of RT based on continuous monitoring\n* The response to mechanical ventilatiory adjustments Participants will be included as soon as neuromuscular blockers (NMB)/sedation is stopped or in case of spontaneous respiratory efforts detection, whatever happens first. Continuous monitoring will be performed by esophageal manometry until switch to a pressure support (spontaneous) mode, restart of deep sedation/neuromuscular blockers by medical indication, or death.\n\nIn order to allow detection of possible RT in patients with ongoing sedation/NMB, mechanical ventilator waveforms will be screened every 1-2 hours by investigators and critical care physicians with at least 1 year of specific training in detection of dyssynchronies.', 'detailedDescription': "Measurements:\n\nAn esophageal catheter for manometry will be placed as usual practice with confirmation of adequate position with the Baydur's occlusion test before recordings. An independent flow sensor and pressure transducer will be placed and connected to a laptop computer to obtain real-time monitoring along with continuous recordings, which then will be off-line analyzed by two experts, for confirmation of RT and characterization.\n\nData collection:\n\nMain cause of the acute respiratory failure and days on mechanical ventilation until enrollment will be collected as well as demographic characteristics, including APACHE II, SOFA and the previous requirement of prone positioning therapy.\n\nAt identification of the RT, drugs for sedation and analgesia, time from initiation of mechanical ventilation to RT identification and blood gas analysis will be recorded. Ventilatory settings will also be collected, including the control variable of the ventilatory mode (volume or pressure), respiratory rate, received tidal volume in ml/kg of predicted body weight, maximum inspiratory flow, ratio of partial arterial oxygen pressure (pO2) to fraction of inspired oxygen (FiO2), driving pressure and (positive end-expiratory pressure (PEEP). Data about esophageal pressure related to RT will also be recorded, including the magnitude of pressure swing, phase angle, coefficient of variation, RT phenotype, entrainment ratio and the presence of breath stacking.\n\nPatient-centered outcomes including length of mechanical ventilation, intensive care and hospital length of stay, and mortality will be followed-up until 60 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated patients with acute respiratory distress syndrome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ARDS according to the Berlin criteria and added New Global Definition 2023\n* Mechanical ventilation\n\nExclusion Criteria:\n\n* \\<18 years\n* Tracheostomy status\n* Pneumothorax\n* Tube thoracostomy with air leaks'}, 'identificationModule': {'nctId': 'NCT06148467', 'acronym': 'RT-CHASERS', 'briefTitle': 'Reverse Trigger Phenotypification and Response to Ventilatory Adjustments', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'officialTitle': 'Incidence of Reverse Trigger Phenotypes and Response to Ventilatory Adjustments in Patients With ARDS', 'orgStudyIdInfo': {'id': '260/22'}}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Guadalajara', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Miguel Ibarra-Estrada, MD', 'role': 'CONTACT', 'email': 'drmiguelibarra@hotmail.com', 'phone': '3317593502'}, {'name': 'Guadalupe Aguirre-Avalos, MD', 'role': 'CONTACT', 'email': 'guadalupe.aavalos@academicos.udg.mx'}, {'name': 'Quetzalcóatl Chávez-Peña, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arnulfo López-Pulgarín, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guadalupe Aguirre-Avalos, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miguel Ibarra-Estrada, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Hernández-Lugo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Civil Fray Antonio Alcalde', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'centralContacts': [{'name': 'Miguel Ibarra-Estrada, MD', 'role': 'CONTACT', 'email': 'drmiguelibarra@hotmail.com', 'phone': '+523317593502'}], 'overallOfficials': [{'name': 'Miguel Ibarra Estrada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Civil Fray Antonio Alcalde'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Miguel Á Ibarra-Estrada', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}}