Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 2:49 AM
Study NCT ID:
NCT06402903
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapy in Patients in a Cardiac Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess length of stay in the Intensive Care Unit', 'timeFrame': 'Screening visit', 'description': 'This period shall be calculated (in days) by subtracting the date of admission to the Intensive Care Unit from the date of discharge from the Intensive Care Unit.'}, {'measure': 'Assess time from hospital admission to medical discharge', 'timeFrame': 'Screening visit', 'description': 'This period shall be calculated (in days) by subtracting the date of admission to the Intensive Care Unit from the date of discharge.'}], 'secondaryOutcomes': [{'measure': 'Assess the age', 'timeFrame': 'Screening visit', 'description': 'This quantitative variable will indicate the age of the patients (in years of age) at the time of admission to the Intensive Care Unit.'}, {'measure': 'Assess the gender', 'timeFrame': 'Screening visit', 'description': 'This dichotomous variable (Female / Male) will indicate the sex of the patient at the time of admission to the Intensive Care Unit.'}, {'measure': 'Assess the weight', 'timeFrame': 'Screening visit', 'description': "The weight at the time of the patient's admission to the hospital will be assessed (in kg)"}, {'measure': 'Assess the administration of a physiotherapy intervention', 'timeFrame': 'Screening visit', 'description': 'This dichotomous variable (Yes / No) will indicate whether the patient has received physiotherapy intervention during his/her stay in the Intensive Care Unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physiotherapy', 'Intensive Care Unit', 'Postoperative complications prevention', 'Cardiac surgery'], 'conditions': ['Cardiac Surgery Patients']}, 'descriptionModule': {'briefSummary': 'Background. Cardiovascular diseases are a major cause of morbidity and mortality. The management of these patients requires multidisciplinary therapeutic approaches. Physiotherapy plays a fundamental role in the postoperative management of patients undergoing cardiac surgery.\n\nObjective: To analyse the relationship between the administration of a physiotherapy intervention and the time spent in the cardiac ICU and on the ward.\n\nMethod. Retrospective cohort study. The medical records of 110 patients undergoing cardiac surgery who received a Physiotherapy intervention during their stay in the Intensive Care Unit will be analysed. Data will be collected from patients admitted to the cardiac ICU in 2023. The variables assessed will be: length of stay in ICU and hospital admission (days), age (years completed), weight (kg) and sex. A one-factor analysis of variance will be performed to calculate the association between the variables and a linear regression analysis will be used to describe the hospital stay variables as a function of the other predictor variables.\n\nExpected outcomes. Physiotherapy treatment in an Intensive Care Unit improves ICU and hospital stay times in patients undergoing cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The data will be collected in May 2024 at the Physical Medicine and Rehabilitation Service of the Hospital Universitario Central de Asturias (HUCA), belonging to the Health Area IV of the Health Service of the Principality of Asturias.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with cardiac pathology\n* Undergoing cardiac surgery at the Hospital Universitario Central de Asturias between 1 January and 31 March 2023\n* In the postoperative phase in the Intensive Care Unit and subsequently on transfer to the ward, they received physiotherapy treatment or not.\n* That the period of stay in the ICU was less than 30 days.\n\nExclusion Criteria:\n\n* Patients with comorbidities prior to surgery that hindered independence from third parties in the performance of activities of daily living and ambulation; iii) patients with previous cardiac surgeries; and iv) patients whose study variables were not fully recorded in the Medical History.\n* Patients with previous cardiac surgeries\n* Patients whose study variables were not fully recorded in the Clinical History.'}, 'identificationModule': {'nctId': 'NCT06402903', 'briefTitle': 'Physiotherapy in Patients in a Cardiac Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Physiotherapy in Patients in a Cardiac Intensive Care Unit. A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'FisCard'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observacional group', 'description': 'The data will be collected in April 2024 at the Physical Medicine and Rehabilitation Service of the Central University Hospital of Asturias (HUCA), belonging to Health Area IV of the Health Service of the Principality of Asturias.', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'The clinical, post-surgical and anthropometric variables of the patients, as well as the time spent in the Intensive Care Unit and on the hospital ward (in days) were collected in the Clinical Histories.\n\nThe collection of data from the Clinical Histories will be carried out by the principal investigator, an employee of the Hospital Universitario Central de Asturias, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the patients whose data were collected.\n\nThe data from the Clinical Histories will be exported to an Excel file which will subsequently be anonymised. Access to the Excel file will require a password access that will be managed from a computer of the University of Oviedo (Department of Surgery and Medical-Surgical Specialties).', 'armGroupLabels': ['Observacional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'University of Oviedo', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ruben Cuesta Barriuso', 'investigatorAffiliation': 'University of Oviedo'}}}}