Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT02576132
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2015-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillometry for Pain Assessment in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2015-10-09', 'studyFirstSubmitQcDate': '2015-10-13', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation coefficient of pupillary light reflex amplitude and pain score', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay', 'description': 'Pain is measured by Numeric Rating Scale - Visualised or Behavioural Pain Scale or Behavioral Pain Scale - Non Intubated and pupillary light reflex amplitude is measured by pupillometry'}], 'secondaryOutcomes': [{'measure': 'Minimal pupil size [mm]', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}, {'measure': 'Maximal pupil size [mm]', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}, {'measure': 'Contraction speed of pupil [mm/s]', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}, {'measure': 'Latency of pupil [ms]', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}, {'measure': 'Pupillary light reflex [%]', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}, {'measure': 'Richmond Agitation Sedation Scale (RASS)', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}, {'measure': 'Glasgow Coma Scale (GCS)', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}, {'measure': 'Delirium', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay', 'description': 'Delirium is measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)'}, {'measure': 'Duration of mechanical ventilation (hours)', 'timeFrame': 'Participants will be followed up during their intensive care unit stay, an average of 25 days'}, {'measure': 'Intensive care unit length of stay (days)', 'timeFrame': 'Participants will be followed up during their intensive care unit stay, an average of 25 days'}, {'measure': 'Hospital length of stay (days)', 'timeFrame': 'Participants will be followed up during their hospital length of stay, an average of 5 weeks'}, {'measure': 'Hospital mortality (days)', 'timeFrame': 'Participants will be followed up during their hospital length of stay, an average of 5 weeks'}, {'measure': 'Discharge to home [%]', 'timeFrame': 'Participants will be followed up during their hospital length of stay, an average of 5 weeks'}, {'measure': 'Morbidity Scores', 'timeFrame': 'Participants will be followed up during their intensive care unit stay, an average of 25 days'}, {'measure': 'Amount of administered drugs', 'timeFrame': 'Participants will be followed up to 6 days during their intensive care unit stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'This study was part of a quality improvement project at the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.\n\nBeing in pain is reported to be one of the most important stressors in critically ill patients and worsens outcome. The evaluation of pain using validated scores in patients who are able to self-report significantly improves the quality of analgesic therapy and health related outcomes in intensive care patients.\n\nHowever, behavioral pain score that are used in sedated or delirious patients, often underestimate the severity of pain.\n\nThe primary aim of this study is to investigate if measurement of the pupillary light reflex Amplitude correlates with the results of pain assessment using validated pain scores in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients, aged 18 years or older with an expected intensive care unit length of stay of of at least 48 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill patients\n* aged 18 years or older\n* patients with an expected intensive care unit length of stay of of at least 48 hours.\n\nExclusion Criteria:\n\n* not German speaking\n* traumatic brain injury\n* stroke\n* increased intracranial pressure\n* ocular disease or surgery.'}, 'identificationModule': {'nctId': 'NCT02576132', 'briefTitle': 'Pupillometry for Pain Assessment in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Pupillometry for Pain Assessment in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'Vola-ICU'}}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia Spies, MD Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charité - Univeritätsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Anesthesiology and Intensive Care Medicine CVK/CCM', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}