Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06260202
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2024-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrition Under Noninvasive Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caloric and protein gap', 'timeFrame': 'At ICU discharge, a median of six days', 'description': 'to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients for every day of ICU stay'}], 'secondaryOutcomes': [{'measure': 'Nutrition modalities outcomes', 'timeFrame': 'At ICU discharge, a median of six days', 'description': 'to evaluate the difference of the mean caloric and protein intake among groups of patients undergoing different nutritional modality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Noninvasive Ventilation', 'Nutrition Therapy', 'Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'Even though nutrition is a fundamental component of Intensive care unit (ICU) therapy, critically ill patients are frequently malnourished, a factor well known for its strong association with a higher risk of complications, prolonged ICU/hospital length of stay, and greater ICU readmission and mortality rates. Noninvasive ventilation (NIV) use has increased considerably over the past twenty years, making this supportive technique a keystone of acute respiratory failure (ARF) treatment. In this setting, respiratory support is provided through an interface, usually a mask or a helmet, that frequently represents an important obstacle to nutrition delivery, making oral intake impossible and posing the necessity to start enteral (EN) or parenteral nutrition (PN). Moreover, while critical care guidelines regarding nutritional management of patients receiving mechanical ventilation (MV) are well established, data and recommendations about the appropriate nutritional support to patients in NIV are still very limited. Due to this limited data, we want to describe characteristics and nutritional management of patients undergoing NIV in ICU, and to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients. Secondarily, we want to evaluate the difference of the caloric and protein intake among groups of patients undergoing different nutritional modality and to assess potential associations of the nutritional characteristics with patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to the Intensive Care Unit of Maggiore della Carità University Hospital from March 1st 2020 to February 28th 2023, undergoing noninvasive ventilation for any diagnosis of acute respiratory failure and for any cause (to avoid endotracheal intubation, as alternative to invasive ventilation, as weaning from invasive ventilation) will be considered.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients;\n* Admission to the Intensive Care Unit of Maggiore della Carità University Hospital from March 1st 2020 to February 28th 2023;\n* Noninvasive ventilation treatment for acute respiratory failure of any cause;\n* Duration of noninvasive ventilation treatment of more than two days;\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Patients under 18 years of age;\n* Duration of noninvasive ventilation treatment of less than two days.'}, 'identificationModule': {'nctId': 'NCT06260202', 'acronym': 'NUTRINIV', 'briefTitle': 'Nutrition Under Noninvasive Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi del Piemonte Orientale Amedeo Avogadro'}, 'officialTitle': 'Nutrition Under Noninvasive Ventilation in Critically Ill Patients: a Retrospective Monocentric Analysis', 'orgStudyIdInfo': {'id': '308.273'}}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Università del Piemonte Orientale', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi del Piemonte Orientale Amedeo Avogadro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francesca Moretto', 'investigatorAffiliation': 'Università degli Studi del Piemonte Orientale Amedeo Avogadro'}}}}