Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 11:44 PM
Study NCT ID:
NCT05469633
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2022-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cross-sectional area of the antrum (CSA)', 'timeFrame': 'Before the painless electronic gastroscopy', 'description': 'The maximum anteroposterior diameter (recorded as D1) and maximum craniocaudal diameter (recorded as D2) between the gastric antrum serosal surfaces were measured perpendicularly to each other.CSA(cm2) = (π × D1 × D2) / 4'}, {'measure': 'Predicted volume', 'timeFrame': 'Before the painless electronic gastroscopy', 'description': 'Predicted volume calculated by CSA'}, {'measure': 'Observed volume', 'timeFrame': 'Before the painless electronic gastroscopy', 'description': 'All gastric fluid was thoroughly suctioned through an endoscope side port, measured to the nearest mL and recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric ultrasound', 'gastric contents', 'painless electronic gastroscope'], 'conditions': ['Ultrasound Evaluation of Gastric Contents']}, 'descriptionModule': {'briefSummary': 'To explore the correlation between gastric ultrasound evaluation and gastroscopic direct vision evaluation of gastric contents, so as to more accurately use gastric ultrasound to evaluate the gastric contents of patients undergoing painless electronic gastroscopy in the outpatient department, so as to develop an individual painless diagnosis and treatment strategy to reduce the risk of lung aspiration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients undergoing painless electronic gastroscopy were fasted for 8 hours in acccordance with gastroscopy guidelines', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18years\n* Patients undergoing painless electronic gastroscopy.\n* Voluntarily participate and sign informed consent.\n\nExclusion Criteria:\n\n* Patients undergoing general electronic gastroscopy.\n* Patients who refused to undergo gastric ultrasound.\n* Patients with postural difficulties during gastric ultrasonography.\n* with fresh wounds or infections at the site of Gastric ultrasound\n* Patients whose ultrsound image quality is too poor to properly display the relevant anatomical structures.'}, 'identificationModule': {'nctId': 'NCT05469633', 'briefTitle': 'Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy', 'orgStudyIdInfo': {'id': 'ultrasound and contents'}}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The Second Affiliated Hospital, Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Chen Yupei', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology,The Second Affiliated Hospital ,Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}