Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-08 @ 11:21 PM
Study NCT ID:
NCT06635018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pulse Oximeter Device on Measured Perfusion Index Values
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Interventional prospective single-arm study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction', 'timeFrame': '1 hour', 'description': 'Perfusion index values will be measured and compared using pulse oximeters from different manufacturers under various conditions, including resting state, movement artifacts, and circulatory restriction. This evaluation will provide a direct comparison of the variability in perfusion index measurements across devices under each condition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perfusion index', 'Pulse oximetry', 'Nociception during Anesthesia'], 'conditions': ['Perfusion Index']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts.', 'detailedDescription': 'Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. It can be used as an indicator of the severity of health status in different groups of critically ill patients, e.g. in patients with sepsis, in patients after cardiac arrest, for early detection of critical heart defects, for indirect assessment of patient pain, as an indicator of fluid therapy and reactivity, or for assessment and evaluation of anaesthesia in the operating room. However, there is currently no standardised calculation of PI and different manufacturers use different algorithms for the calculation. The consequence is that absolute measured values cannot be compared between devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Adult Volunteer\n\nExclusion Criteria:\n\n* Post-traumatic upper limb conditions affecting finger perfusion\n* Injuries or diseases of the skin of the fingers\n* Any acute phase of any disease'}, 'identificationModule': {'nctId': 'NCT06635018', 'acronym': 'PICOMP', 'briefTitle': 'Effect of Pulse Oximeter Device on Measured Perfusion Index Values', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Effect of Pulse Oximeter Device on Measured Perfusion Index Values', 'orgStudyIdInfo': {'id': 'NVT_01_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index', 'description': 'Three finger pulse oximeter sensors from different manufacturers are placed on the middle fingers of one hand. Three interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction).', 'interventionNames': ['Other: Resting conditions', 'Other: Movement artifacts', 'Other: Circulation constriction']}], 'interventions': [{'name': 'Resting conditions', 'type': 'OTHER', 'description': "The volunteer's hands are at rest and PI readings are taken for six minutes. After two minutes, there is always a randomized rotation of the sensors between the fingers.", 'armGroupLabels': ['Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index']}, {'name': 'Movement artifacts', 'type': 'OTHER', 'description': 'The volunteer periodically spreads his/her fingers and clenches them into a fist, and PI readings are taken for six minutes. After two minutes there is always a randomized rotation of sensors between the fingers.', 'armGroupLabels': ['Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index']}, {'name': 'Circulation constriction', 'type': 'OTHER', 'description': "The volunteer's arm is constricted using a cuff to measure non-invasive blood pressure. The perfusion index value is monitored during the time of cuff pressure and cuff release. The measurement is followed by a 4-minute pause to allow the vascular supply to stabilize, the sensors are randomly rotated, and the measurement is repeated.", 'armGroupLabels': ['Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Simon Walzel, MEng', 'role': 'CONTACT', 'email': 'walzesim@fbmi.cvut.cz', 'phone': '420724836120'}, {'name': 'Karel Roubik, Prof.', 'role': 'CONTACT', 'email': 'roubik@fbmi.cvut.cz'}], 'overallOfficials': [{'name': 'Karel Roubik, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Czech Technical University, Fac. of Biomedical Engineering'}]}, 'ipdSharingStatementModule': {'url': 'https://ventilation.fbmi.cvut.cz/data/', 'infoTypes': ['SAP'], 'timeFrame': 'Unlimited from the time of processing complete measured data', 'ipdSharing': 'YES', 'description': 'The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/', 'accessCriteria': 'Publicly available to everyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}