Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT02916004
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2018-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)', 'timeFrame': '10 seconds after nociceptive stimulation'}, {'measure': 'Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)', 'timeFrame': '10 seconds after nociceptive stimulation'}], 'secondaryOutcomes': [{'measure': 'Comparison NFR and the standard of care pain assessment (behavior pain scale)', 'timeFrame': 'In period of routine two hourly check up by nurse', 'description': 'Routine assessment of pain by attending nurse'}, {'measure': 'Comparison PDR and the standard of care pain assessment (behavior pain scale)', 'timeFrame': 'In period of routine two hourly check up by nurse', 'description': 'Routine assessment of pain by attending nurse'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Analgesia', 'Pain measurement', 'Nociception', 'Electromyography', 'Electrical stimulation', 'Pupillometry', 'Critical care', 'Sedation'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients.\n\nPatients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)', 'detailedDescription': 'Pupillary dilatation reflex: tetanic stimulations at the nervus medianus were performed starting form 10 milliamperes (mA) up to 60mA. Pupillary diameter was measured before, during and after stimulation.\n\nNociception flexion reflex: tetanic stimulations at the nervus suralis were performed starting form 0.5mA in increasing steps via an automated RIII (NFR) threshold tracking model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Critically ill with necessity to mechanic ventilation\n* Hospitalized at the ICU of our institution\n* Started sedation protocol (propofol/remifentanil or propofol/sufentanil)\n* Approved informed consent by family member or relative.\n\nExclusion Criteria:\n\n* Known eye deformity or extented ophthalmologic surgery in history\n* Severe traumatic brain injury of fulminant stroke\n* Known (poly)neuropathy of complicated diabetes\n* Need for continuously curarization\n* Hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT02916004', 'briefTitle': 'The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Responsiveness to Noxious Stimuli in Ventilated Intensive Care Unit (ICU) Patients With Propofol / Remifentanil Sedation Protocol by Using the Nociception Flexion Reflex (RIII Reflex) and the Pupillary Dilatation Reflex.', 'orgStudyIdInfo': {'id': '16/33/334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Measurement of NFR and PDR', 'description': 'Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)', 'interventionNames': ['Device: Measurement of NFR and PDR']}], 'interventions': [{'name': 'Measurement of NFR and PDR', 'type': 'DEVICE', 'description': 'Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment', 'armGroupLabels': ['Measurement of NFR and PDR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'University hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'overallOfficials': [{'name': 'Davina Wildemeersch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Davina Wildemeersch', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}