Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-04 @ 3:00 AM
Study NCT ID:
NCT01838304
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2013-04-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Probability Ramp Control of Propofol for EGD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'roderic.eckenhoff@uphs.upenn.edu', 'phone': '(215) 662-3766', 'title': 'Vice-Chair of Research', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Choice of processed EEG scores in power analyasis; variability of PSI scores; lack of concealed allocation, as it was deemed unethical to ask the CRNAs to deliver "sham propofol" in the experimental arm.'}}, 'adverseEventsModule': {'timeFrame': 'Duration of sedation (mean 25 minutes)', 'eventGroups': [{'id': 'EG000', 'title': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing\n\nMonitoring: Manual recording of drug doses determined by CRNA', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Probability Ramp Control', 'description': 'Propofol titrated to deep sedation using PRC software.\n\nProbability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Desaturation', 'notes': 'Patient required bag-mask ventilation due to desaturation following propofol administration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Requiring Adjustment in Propofol Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing\n\nMonitoring: Manual recording of drug doses determined by CRNA'}, {'id': 'OG001', 'title': 'Probability Ramp Control', 'description': 'Propofol titrated to deep sedation using PRC software.\n\nProbability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraprocedure (average of 9 minutes)', 'description': 'Following initial sedation, an infusion rate for propofol is determined by the CRNA (control) or software (experimental). If this rate is appropriate for the duration of the brief procedure, no adjustment to the rate will be required. A greater requirement for rate changes suggests that the anesthesia provider needs to be immediately available to perform these adjustments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decrease in Minute Ventilation From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing\n\nMonitoring: Manual recording of drug doses determined by CRNA'}, {'id': 'OG001', 'title': 'Probability Ramp Control', 'description': 'Propofol titrated to deep sedation using PRC software.\n\nProbability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '30'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of sedation (average of 25 minutes)', 'description': 'Minute ventilation as determined by respiratory inductance plethysmography from initiation of sedation until emergence.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Spent Below a Saturation of 80%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'seconds', 'counts': [{'value': '29686', 'groupId': 'OG000'}, {'value': '30552', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing\n\nMonitoring: Manual recording of drug doses determined by CRNA'}, {'id': 'OG001', 'title': 'Probability Ramp Control', 'description': 'Propofol titrated to deep sedation using PRC software.\n\nProbability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.9', 'ciLowerLimit': '4.21', 'ciUpperLimit': '14.81', 'groupDescription': "Fisher's exact test for odd's ratio of time below a saturation of 80% to total time", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Duration of sedation (mean 25 minutes)', 'description': 'Number of seconds spent below saturation of 80%, reported as the total per group', 'unitOfMeasure': 'seconds', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'seconds', 'denomUnitsSelected': 'seconds'}, {'type': 'SECONDARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing\n\nMonitoring: Manual recording of drug doses determined by CRNA'}, {'id': 'OG001', 'title': 'Probability Ramp Control', 'description': 'Propofol titrated to deep sedation using PRC software.\n\nProbability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient'}], 'classes': [{'categories': [{'measurements': [{'value': '9.03', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '4.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Procedure time (average of 9 minutes)', 'description': 'Time from endoscopic intubation until completion of the procedure. This is not really an outcome measure, but is used to assess balance between groups.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing\n\nMonitoring: Manual recording of drug doses determined by CRNA'}, {'id': 'FG001', 'title': 'Probability Ramp Control', 'description': 'Propofol titrated to deep sedation using PRC software.\n\nProbability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing\n\nMonitoring: Manual recording of drug doses determined by CRNA'}, {'id': 'BG001', 'title': 'Probability Ramp Control', 'description': 'Propofol titrated to deep sedation using PRC software.\n\nProbability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '16.5', 'groupId': 'BG001'}, {'value': '50.625', 'spread': '15.345', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA 3', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'American Society of Anesthesia physical status rating. ASA 1 = Healthy ASA 2 = Minor illness (i.e. hypertension) ASA 3 = Major illness (i.e. S/P myocardial infarction)', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.3', 'spread': '27.4', 'groupId': 'BG000'}, {'value': '82.1', 'spread': '23.9', 'groupId': 'BG001'}, {'value': '82.22', 'spread': '25.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2013-04-12', 'resultsFirstSubmitDate': '2017-05-03', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-19', 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Requiring Adjustment in Propofol Dosing', 'timeFrame': 'Intraprocedure (average of 9 minutes)', 'description': 'Following initial sedation, an infusion rate for propofol is determined by the CRNA (control) or software (experimental). If this rate is appropriate for the duration of the brief procedure, no adjustment to the rate will be required. A greater requirement for rate changes suggests that the anesthesia provider needs to be immediately available to perform these adjustments.'}], 'secondaryOutcomes': [{'measure': 'Decrease in Minute Ventilation From Baseline', 'timeFrame': 'Duration of sedation (average of 25 minutes)', 'description': 'Minute ventilation as determined by respiratory inductance plethysmography from initiation of sedation until emergence.'}, {'measure': 'Time Spent Below a Saturation of 80%', 'timeFrame': 'Duration of sedation (mean 25 minutes)', 'description': 'Number of seconds spent below saturation of 80%, reported as the total per group'}, {'measure': 'Procedure Time', 'timeFrame': 'Procedure time (average of 9 minutes)', 'description': 'Time from endoscopic intubation until completion of the procedure. This is not really an outcome measure, but is used to assess balance between groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['propofol sedation endoscopy'], 'conditions': ['Gastrointestinal Disease']}, 'referencesModule': {'references': [{'pmid': '22467886', 'type': 'BACKGROUND', 'citation': 'Mandel JE, Sarraf E. The variability of response to propofol is reduced when a clinical observation is incorporated in the control: a simulation study. Anesth Analg. 2012 Jun;114(6):1221-9. doi: 10.1213/ANE.0b013e31824cb853. Epub 2012 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic sedation requires titration of propofol to deep sedation without minimum overshoot into general anesthesia. This skill is demanding and acquired slowly. Probability Ramp Control (PRC) simplifies this by providing the clinician with a simple infusion sequence that permits gradual titration of propofol. The purpose of this study is to compare the performance of this technology to that of experienced anesthesia providers in endoscopic sedation.', 'detailedDescription': 'Administration of propofol to achieve a target of moderate sedation is a challenging task for which anesthesia providers receive minimal training. Undersedation results in a noncompliant patient, while oversedation results in airway obstruction, respiratory depression, and hypotension. Considerable variability in patient pharmacokinetics (the distribution of drug within the body) and pharmacodynamics (the translation of drug concentration to clinical effect) has been demonstrated. The skill of titrating propofol to the desired target and maintaining this state is slowly acquired in the clinical environment of the endoscopy center with frequent reliance on rescue skills. An automated system that facilitates this process would be useful.\n\nPharmacokinetic models allow us to make predictions of the results of drug administration. If we know the age and size of the patient, we can determine a quantity of propofol that will attain a desired concentration at some point in the future (within the predictive accuracy of the model). If they are old, this is less than if they are young. If they are obese, this is more than if they are thin. By adjusting the dosing, we can achieve similar concentrations at a specified time in a wide range of patients.\n\nPharmacodynamic models allow us to relate drug concentration to a probability of response. Sensitivity is a randomly distributed variable, and the cumulative probability of response to propofol is well represented by a sigmoid curve. While we do not know the concentration that will suffice for a given individual, we can determine the probability that this individual will lose responsiveness within an interval of concentrations. For example, the probability of loss of responsiveness between 1 µg/ml and 6 µg/ml is around 99%. For any given age and size, an infusion sequence can be determined so that we traverse this interval smoothly. The infusion sequence is determined by minimization of the difference between the simulated probability and the target (1). We predict that 90% of 50 year old 70 kg patients will lose responsiveness between one minute and three minutes after initiating the infusion, and 99% by five minutes. The infusion sequence for this patient is comprised of a bolus of 287 µg/kg followed by an initial infusion of 216 µg/kg/min, with an increase to 550 µg/kg/min after 147 seconds. By selecting the infusion sequence based on the age and size of the patient, all patients will track the same target line. These infusion rates are determined prior to initiation of sedation, and the clinician can verify that they are appropriate for the patient before beginning sedation.\n\nOnce the endpoint of adequate sedation is observed, the effect site concentration associated with this endpoint is inferred, and the infusion that will maintain this concentration can be determined. This allows the clinical observation to be translated into an infusion rate, much as a driver accelerates to a desired speed and then engages the cruise control to maintain that speed.\n\nThe intent of this study is to demonstrate equivalent safety and efficacy of PRC to control by a skilled clinician.\n\nReferences\n\n1\\. Mandel JE, Sarraf E. The Variability of Response to Propofol Is Reduced When a Clinical Observation Is Incorporated in the Control: A Simulation Study. Anesthesia \\& Analgesia. 2012;114:1221-9.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for elective EGD\n\nExclusion Criteria:\n\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01838304', 'briefTitle': 'Probability Ramp Control of Propofol for EGD', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Prospective, Randomized Comparison of Depth of Sedation With Propofol Titrated by Probability Ramp Control to Control by Anesthesia Providers During Esophagogastroduodenoscopy (EGD)', 'orgStudyIdInfo': {'id': '817166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Monitoring', 'description': 'Standard of care sedation by CRNA using proposal with manual recording of drug dosing', 'interventionNames': ['Device: Monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Probability ramp control', 'description': 'Propofol titrated to deep sedation using PRC software.', 'interventionNames': ['Device: Probability ramp control']}], 'interventions': [{'name': 'Probability ramp control', 'type': 'DEVICE', 'description': 'Decision support software that calculates propofol doses appropriate for age and weight of the patient', 'armGroupLabels': ['Probability ramp control']}, {'name': 'Monitoring', 'type': 'DEVICE', 'otherNames': ['Manual recording of drug doses determined by CRNA'], 'description': 'Manual recording of drug doses determined by CRNA', 'armGroupLabels': ['Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Endoscopy Center, Perelman Center for Advanced Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jeff E Mandel, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}