Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-04 @ 7:07 PM
Study NCT ID:
NCT01505933
Status:
TERMINATED
Last Update Posted:
2019-07-11
First Post:
2011-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056151', 'term': 'Airway Remodeling'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uparekh@pennstatehealth.psu.edu', 'phone': '717531-4264', 'title': 'Dr. Uma R Parekh, MBBS, DNB, FRCA, FFARCSI', 'organization': 'Penn State Health Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects recruited.'}}, 'adverseEventsModule': {'timeFrame': 'through study procedure up to subject discharge, an average of 2 hour', 'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Propofol', 'description': 'Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0'}], 'classes': [{'title': 'CSA of the Soft Palate', 'categories': [{'measurements': [{'value': '132.1', 'spread': '75.9', 'groupId': 'OG000'}, {'value': '103.9', 'spread': '50.8', 'groupId': 'OG001'}]}]}, {'title': 'CSA of the Base of Tongue', 'categories': [{'measurements': [{'value': '122.0', 'spread': '82.1', 'groupId': 'OG000'}, {'value': '68.9', 'spread': '38.3', 'groupId': 'OG001'}]}]}, {'title': 'CSA of the Tip of the Epiglottis', 'categories': [{'measurements': [{'value': '47.6', 'spread': '41.5', 'groupId': 'OG000'}, {'value': '81.6', 'spread': '69.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done', 'description': 'At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.', 'unitOfMeasure': 'mm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0'}], 'classes': [{'title': 'AP of the Soft Palate', 'categories': [{'measurements': [{'value': '10.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'AP of the Base of the Tongue', 'categories': [{'measurements': [{'value': '11.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'AP of the Tip of the Epiglottis', 'categories': [{'measurements': [{'value': '11.0', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtained', 'description': 'At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0'}], 'classes': [{'title': 'Tr of the Soft Palate', 'categories': [{'measurements': [{'value': '14.6', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Tr of the Base of the Tongue', 'categories': [{'measurements': [{'value': '12.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Tr of the Tip of the Epiglottis', 'categories': [{'measurements': [{'value': '12.6', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtained', 'description': 'At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.\n\nAfter the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.'}, {'id': 'FG001', 'title': 'Propofol', 'description': 'propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.\n\nAfter the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.\n\nImage acquisitions will be repeated approximately 5 min after the increase in infusion rate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1 participant was excluded prior to assignment group'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine', 'description': 'Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.\n\nAfter the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.'}, {'id': 'BG001', 'title': 'Propofol', 'description': 'propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.\n\nAfter the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.\n\nImage acquisitions will be repeated approximately 5 min after the increase in infusion rate.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3.5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3.75', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-26', 'size': 260369, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-26T10:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'finding it difficult to recruit.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2011-07-07', 'resultsFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2012-01-04', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-10', 'studyFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis', 'timeFrame': 'When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done', 'description': 'At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.'}], 'secondaryOutcomes': [{'measure': 'Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis', 'timeFrame': 'When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtained', 'description': 'At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged'}, {'measure': 'Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis', 'timeFrame': 'When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtained', 'description': 'At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['upper', 'airway', 'dimensions', 'propofol', 'dexmedetomidine'], 'conditions': ['Airway Remodeling']}, 'descriptionModule': {'briefSummary': 'Sedation is required in infants and children to successfully complete MRI while maintaining respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk during MRI examination. Therefore, appropriate drugs need to be selected, administered, and titrated to achieve these objectives. Propofol is commonly used for sedation in children in the MRI setting because of its predictability, rapid onset, and offset of action. Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and respiratory stability. The rationale of this research is to assess the effect of these drugs on the upper airway and validate their use in children with upper airway disorders.', 'detailedDescription': 'Objectives The objective of this study is to compare the changes in upper airway configuration at the level of soft palate, base of tongue and tip of the epiglottis in children sedated with dexmedetomidine and propofol in children undergoing MRI.\n\nWe hypothesize that the upper airway caliber will be smaller in children receiving propofol than with dexmedetomidine.\n\nPrimary Outcome To measure the cross-sectional area (CSA) of the upper airway at the level of soft palate, base of the tongue and epiglottis in both groups of children at high doses of propofol and dexmedetomidine and thus compare the decrease in CSA with increasing doses of both drugs.\n\nSecondary Outcomes To measure the\n\n* anteroposterior (AP) diameter\n* transverse (Tr) diameter of the upper airway at the three levels in both groups of children at both low and high doses of propofol and dexmedetomidine and compare the decrease in AP and Tr diameter at increasing doses of dexmedetomidine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing MRI brain\n* Age 2 - 5 yrs\n* ASA I - II\n\nExclusion Criteria:\n\n* OSA\n* Pathology of upper airway\n* Craniofacial anomalies\n* Gastroesophageal reflux\n* Increased intracranial pressure\n* Body weight of 20% more than ideal\n* Contraindication to the use of either drug\n* Failure to maintain a patent airway during the study'}, 'identificationModule': {'nctId': 'NCT01505933', 'briefTitle': 'Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Comparison of Changes in Upper Airway Dimensions With Dexmedetomidine and Propofol in Children Undergoing MRI', 'orgStudyIdInfo': {'id': '35165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'propofol', 'interventionNames': ['Drug: propofol']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['alpha 2 agaonist'], 'description': 'Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.\n\nAfter the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'propofol', 'type': 'DRUG', 'otherNames': ['induction agent'], 'description': 'Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.\n\nAfter the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.\n\nImage acquisitions will be repeated approximately 5 min after the increase in infusion rate.', 'armGroupLabels': ['propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Uma R Parekh, MBBS, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professsor in Anesthesiology', 'investigatorFullName': 'Uma R Parekh', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}