Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-04 @ 8:43 AM
Study NCT ID:
NCT02090868
Status:
WITHDRAWN
Last Update Posted:
2020-08-27
First Post:
2013-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No patients recruited due to decreased levels of patients requiring non-invasive ventilation during the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mid Arm Circumference Change', 'timeFrame': 'Day 1, 3, 7, 14'}], 'secondaryOutcomes': [{'measure': 'Fluid Intake Change', 'timeFrame': 'Daily over 14 days', 'description': 'fluid intake from all sources eg intravenous, nasogastric, oral'}, {'measure': 'fluid balance change', 'timeFrame': 'daily for 14 days', 'description': 'fluid intake minus fluid output'}, {'measure': 'New formation of or worsening of existing pressure sores', 'timeFrame': 'daily for 14 days'}, {'measure': 'new diagnosis of aspiration pneumonia', 'timeFrame': 'daily for 14 days'}, {'measure': 'number of days requiring non-invasive ventilation', 'timeFrame': '14 days'}, {'measure': 'number of days requiring level 2 care', 'timeFrame': '14 days'}, {'measure': 'length of hospital stay', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Invasive Ventilation', 'Bi-Level Positive Airway Pressure', 'Continuous Positive Airway Pressure', 'Critical Care', 'Nutrition', 'Malnutrition', 'Staff attitudes, knowledge and beliefs'], 'conditions': ['Patients Requiring Non-invasive Ventilation']}, 'descriptionModule': {'briefSummary': "This study aims to explore how the introduction of an oral intake screening tool can benefit patients requiring noninvasive ventilation. The Quality Care Commission has identified nutritional problems in hospital and there is much literature on the importance of nutrition when critically ill. Literature is short however concerning the specialized population of those requiring noninvasive ventilation and they are a high risk group of suffering from malnutrition.\n\nThis study will potentially benefit patients by improving their nutritional care through guided assessment and nurse training.\n\nThe study will use mixed methodology, a prospective cohort study and qualitative interviews. The prospective cohort study will collect data from patients prior to the tool introduction, the control group, and post the tool introduction, the exposure group. This will enable comparisons to be made between the exposure and the control groups.\n\nNurses will be interviewed in semi structured focus groups prior to tool introduction and post to identify themes and sub themes to give a deeper understanding of nutrition in hospital and to examine the use of the tool in practice.\n\nPatients will be eligible if they are over 18 and requiring noninvasive ventilation and nurses will be eligible if they work on the high dependency unit. Patients will be visited daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The other daily visits will involve collecting data, which is recorded as part of routine care.\n\nNurses will undergo 2 focus group interviews and a teaching session. The study will take place at St Mary's hospital funded by Imperial College London. The study will be split into two periods with a two week gap in between. Each period will last until 22 patient participants have been recruited.", 'detailedDescription': 'No patients were recruited to the study due to decreased levels of patients requiring non-invasive ventilation during the study period and time constraints owing to an academic award submission date. Six nurse participants were recruited to the study and underwent two focus group interviews, one prior to tool implementation and one post.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients; Medical High Dependency Unit Patients Staff; Full time employees on the Douglas Acute Admission Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients\n\nInclusion Criteria:\n\n* over 18 years old\n* require non-invasive ventilation as defined by the protocol\n\nExclusion Criteria:\n\n* Patients on the Liverpool Care Pathway\n* Patients requiring nocturnal non-invasive ventilation only\n* Patients with a tracheostomy\n* Patients with a nasogastric feeding tube insitu on admission\n* Patients with a PEG/RIG tube insitu on admission\n\nStaff\n\nInclusion Criteria:\n\n* full time employees\n* work in the medical high dependency unit\n\nExclusion Criteria:\n\n* staff only working bank or agency shifts on the medical high dependency unit\n* staff who have not had formal high dependency/critical care training\n* staff who do not work more than 5 shifts per month in the medical high dependency unit\n* staff who have not held a full time post on Douglas Acute Admissions Unit for more than six months'}, 'identificationModule': {'nctId': 'NCT02090868', 'briefTitle': 'An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'How the Introduction of an Oral Intake Screening Tool Can Benefit Patients Receiving Non-Invasive Ventilation', 'orgStudyIdInfo': {'id': '13IC0065'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre Introduction', 'description': 'Pre tool introduction cohort 22 patient participants who will receive standard care (no patients were recruited)'}, {'label': 'Nurses', 'description': '12 nurse participants who will take part in 2 focus group interviews and a teaching session (6 nurse participants were recruited)'}, {'label': 'Post Introduction', 'description': "Pre tool introduction cohort 22 patient participants who's ability to eat and drink orally will be assessed using the Oral Intake Screening Tool (no patient participants were recruited)", 'interventionNames': ['Other: Oral Intake Screening Tool']}], 'interventions': [{'name': 'Oral Intake Screening Tool', 'type': 'OTHER', 'description': 'A screening tool developed from a literature review and expert opinion. It will be used by nurses to assess patients receiving non-invasive ventilation ability to eat and drink orally and suggest what actions should be taken if they are unable to do so', 'armGroupLabels': ['Post Introduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St Marys Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gary Frost', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}