Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT04759066
Status:
WITHDRAWN
Last Update Posted:
2022-01-03
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The HEALiX™ Intubated Patient (IP) Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group descriptive pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Primary investigator moved to a new institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unplanned removal of devices', 'timeFrame': 'up to 2 weeks', 'description': 'Frequency of unplanned removal of lines and self-extubation'}], 'secondaryOutcomes': [{'measure': 'Ease of device use', 'timeFrame': 'up to 2 weeks', 'description': 'Staff perception of ease of locating the correct size of the device, applying it, caring for the patient using HEALiX, cleaning it after use, and returning it for storage.'}, {'measure': 'Availability of device', 'timeFrame': 'up to 2 weeks', 'description': 'Number of times during the study period that the correct size of HEALiX is not available.'}, {'measure': 'Alternate device use', 'timeFrame': 'up to 2 weeks', 'description': 'Number of patients who have HEALiX device removed by staff and replaced by soft wrist restraints or other limb limiting application, and the reason for removal.'}, {'measure': 'Ease of application', 'timeFrame': 'up to 1 week', 'description': 'Proportion of incorrectly to correctly sized HEALiX applications'}, {'measure': 'Acceptability of device', 'timeFrame': 'up to 1 week', 'description': "Average length of time for a member of the research team to discuss the HEALiX Pilot Study with a patient's family member in person and phone until decision is made about participation"}, {'measure': 'Education around device', 'timeFrame': 'up to 12 weeks', 'description': 'Length of time it takes to train the staff in the three participating Intensive Care Units'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self-extubation', 'non-restraint device', 'removal of lines'], 'conditions': ['Device Ineffective', 'Safety Issues']}, 'descriptionModule': {'briefSummary': 'The current standard of care for limiting the movement of mechanically ventilated critical care patients is the use of physical wrist restraints, which are both ineffective in preventing removal of invasive and adjunct respiratory support devices and have a multitude of negative physical and psychological consequences for the patient. The objective of the proposed research is to test an innovative device designed to allow more freedom of movement of mechanically ventilated patients without bending of the arms, thereby preventing removal of adjunct mechanical ventilation devices and invasive monitoring equipment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* speak English\n* legally authorized representative must speak English\n* admitted by one of the services presiding over the selected intensive care units\n* mechanically ventilated receiving analgesic-sedating medications\n* have soft wrist restraints applied as part of their care plan documented in the medical record to reduce the risk of unplanned removal of medical devices\n\nExclusion Criteria:\n\n* pregnant women\n* prisoners\n* patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale \\<8) for any reason'}, 'identificationModule': {'nctId': 'NCT04759066', 'briefTitle': 'The HEALiX™ Intubated Patient (IP) Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Lancaster General Hospital'}, 'officialTitle': 'Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study', 'orgStudyIdInfo': {'id': 'HEALiX IP Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Participants will wear HEALiX device', 'interventionNames': ['Device: HEALiX']}], 'interventions': [{'name': 'HEALiX', 'type': 'DEVICE', 'description': 'HEALiX is a non-restraint patient safety device', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17602', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Health', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}], 'overallOfficials': [{'name': 'Lisa Caplan, DNP-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn Medicine Lancaster General Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lancaster General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}