Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-18 @ 5:34 PM
Study NCT ID:
NCT03451461
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2018-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asynchronies During Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of asynchronies during mechanical ventilation', 'timeFrame': 'during all period of mechanical ventilation up to the study end, approximately december 2018', 'description': 'Data will be collected through the middleware Better Care, an automatic system of asynchronies detection'}], 'secondaryOutcomes': [{'measure': 'Influence of sedation and analgesia in the incidence of asynchronies', 'timeFrame': 'during all period of mechanical ventilation up to the study end, approximately december 2018', 'description': 'percentage of asynchronies (double cycling, ineffective efforts, short cycling, prolonged cycling, asynchrony index), dose in miligrams per kilogram daily of medication and type of medication administered daily.\n\nMedication data will be collected from the mediacal records daily.'}, {'measure': 'Influence of respiratory mechanics in the incidence of asynchronies', 'timeFrame': 'during all period of mechanical ventilation up to the study end, approximately december 2018', 'description': 'percentage of asynchronies (doublé cycling, ineffective efforts, short cycling, prolonged cycling, asynchrony index, peak pressure in cmH2O, plateau pressure in cmH2O, flow liters/minute, peep in cmH2O, tidal volumen in mililiters, compliance in mililiters/cmH2O, resistances cmH2O/liters per second Respiratory emchanics data will be collected through the middleware Better Care'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asynchronies'], 'conditions': ['Mechanical Ventilation Complication']}, 'referencesModule': {'references': [{'pmid': '35120043', 'type': 'DERIVED', 'citation': 'Magrans R, Ferreira F, Sarlabous L, Lopez-Aguilar J, Goma G, Fernandez-Gonzalo S, Navarra-Ventura G, Fernandez R, Montanya J, Kacmarek R, Rue M, Forne C, Blanch L, de Haro C, Aquino-Esperanza J; ASYNICU group. The Effect of Clusters of Double Triggering and Ineffective Efforts in Critically Ill Patients. Crit Care Med. 2022 Jul 1;50(7):e619-e629. doi: 10.1097/CCM.0000000000005471. Epub 2022 Feb 7.'}, {'pmid': '31277722', 'type': 'DERIVED', 'citation': 'de Haro C, Magrans R, Lopez-Aguilar J, Montanya J, Lena E, Subira C, Fernandez-Gonzalo S, Goma G, Fernandez R, Albaiceta GM, Skrobik Y, Lucangelo U, Murias G, Ochagavia A, Kacmarek RM, Rue M, Blanch L; Asynchronies in the Intensive Care Unit (ASYNICU) Group. Effects of sedatives and opioids on trigger and cycling asynchronies throughout mechanical ventilation: an observational study in a large dataset from critically ill patients. Crit Care. 2019 Jul 5;23(1):245. doi: 10.1186/s13054-019-2531-5.'}]}, 'descriptionModule': {'briefSummary': 'Invasive mechanical ventilation (IMV) is a life support treatment for patients with acute respiratory failure. The IMV can generate adverse effects that may cause alterations in other organs besides the lung, creating an important problem during ICU stay, hospital stay and years after discharge. These consequences on morbidity and mortality have significant economic and social weight. In the United States the IMV represents 2.7 episodes per 1000 habitants, with an estimated cost of $27,000 million, representing 12% of all hospital expenses. The overall mortality in patients with IMV is 30-35%, increasing with age. Therefore, patients receiving IMV are a high-risk population and with higher costs.\n\nA poor interaction between patient and ventilator during IMV can develop asynchronies. The asynchronies may present in 25% of patients. The majority of studies in ICU patients are limited to a evaluation of short periods of time. Asynchronies identification needs the application of respiratory physiology knowledge and the interpretation of respiratory signals from the ventilator waves. This allows identifying in an easy way different situations of "fight", but it also difficult the identification of situation where asynchronies are less obvious, doing that them remain underdiagnosed. Moreover, asynchronies can be only evaluated during a brief period of time, and it\'s difficult to know their incidence during all the IMV period and to make adjustments to improve them.\n\nIn our centre, it has been developed a continuous monitoring system during IMV which integrates, in real-time, all the information derived from digital monitors and ventilators. It allows a continuous and automatic detection of different events (through an intelligent alarm system) and quantification of asynchronies. It was demonstrated that asynchronies are frequent, that it can be present from the beginning of IMV, that it increase in severe patients under deep sedation and it can increase ICU and hospital mortality.\n\nThe investigators can study different factors that can influence over asynchronies development or can improve them.', 'detailedDescription': 'The aim of this study is to analyze the real incidence of asynchronies of patients undergoing mechanical ventilation and to analyze what factors may have an association with their appearance.\n\nThis factors includes factors related with the pulmonary mechanics of each patient and other factors such as the treatment administered, especially drugs with sedative and analgesic effect will be taken into account.\n\nThis can help to implement strategies for the improvement of asynchronies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the ICU under mechanical ventilation and monitorized with the Better Care System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical ventilation more than 48 hours.\n* Included during the first 24 hours of mechanical ventilation.\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Pregnant patients\n* Do-not-resuscitate orders\n* Admitted for organ donation\n* Chest tubes with suspected bronchopleural fistula.'}, 'identificationModule': {'nctId': 'NCT03451461', 'briefTitle': 'Asynchronies During Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Asynchronies During Mechanical Ventilation: Factors Related', 'orgStudyIdInfo': {'id': 'Asynchronies'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Observational study. Clinical data recorded'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Candelaria de Haro', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Manresa', 'country': 'Spain', 'facility': 'Fundació Althaia', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'overallOfficials': [{'name': 'Lluis Blanch, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of Institut Parc Tauli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Candelaria de Haro', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}