Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 10:23 PM
Study NCT ID:
NCT05526105
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2022-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric US in ICU Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D011015', 'term': 'Pneumonia, Aspiration'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be assigned to be NPO after midnight (standard protocol) or feed up until call to OR then decompressed (liberal protocol).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2022-08-15', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric Residual Volumes', 'timeFrame': 'Within one hour of operative intervention.', 'description': 'Quantification of gastric residual volumes as measured in milliliters using antral cross-sectional areas and semi-quantitative gastric volumes using standardized grading scores.'}], 'secondaryOutcomes': [{'measure': 'Comparison of two different NPO protocol populations', 'timeFrame': 'Within four months of study completion, 16 months from study start', 'description': 'Comparing standard ASA NPO protocol vs liberal, feed-up-until-call to OR protocol as defined by comparison of gastric volumes (mLs).'}, {'measure': 'Peri-operative aspiration events', 'timeFrame': 'Within four months of study completion, 16 months from study start', 'description': 'Number of aspiration events per number of operative interventions.'}, {'measure': 'Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols', 'timeFrame': 'Zero to sixteen hours prior to surgery', 'description': 'Calculation of enteral nutrition held during NPO time in kilocalories.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NPO Protocols', 'Intensive Care Unit', 'Gastric Ultrasound', 'Ultrasound', 'Surgical Intensive Care Unit', 'NPO', 'Nasogastric Tube', 'Orogastric Tube', 'Enteral Nutrition', 'Parenteral Nutrition', 'Gastric Residual Volume', 'Aspiration', 'Critical Illness Nutrition'], 'conditions': ['Critical Illness', 'Surgery', 'Aspiration Pneumonia']}, 'descriptionModule': {'briefSummary': 'This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 18 or older, admitted to the ICU, requiring general anesthesia or sedation for a procedure with a pre-existing, cuffed endotracheal or tracheostomy tube. Most patients admitted to the ICU would be unable to consent.\n\nExclusion Criteria:\n\n* Known upper gastrointestinal anatomical problem that would prevent accurate estimation of gastric volume, gastric perforation, pregnancy beyond the first trimester.\n* Lack of a pre-existing, cuffed endotracheal or tracheostomy tube.'}, 'identificationModule': {'nctId': 'NCT05526105', 'briefTitle': 'Gastric US in ICU Patient', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Gastric Ultrasound in Critically Ill Patients for Evaluation of Gastric Volume Residuals; A Comparison of NPO Protocols', 'orgStudyIdInfo': {'id': 'STUDY02001249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard ASA NPO Protocol', 'description': 'Patients will be made NPO at midnight prior to date of surgery.', 'interventionNames': ['Diagnostic Test: Gastric Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Liberal Feeding Protocol', 'description': 'Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube.', 'interventionNames': ['Diagnostic Test: Gastric Ultrasound']}], 'interventions': [{'name': 'Gastric Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Gastric ultrasound in the supine and right lateral decubitus position for patients going for operative intervention with a protected airway.', 'armGroupLabels': ['Liberal Feeding Protocol', 'Standard ASA NPO Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Chiang, MD', 'role': 'CONTACT', 'email': 'laura.m.chiang@hitchcock.org'}], 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'centralContacts': [{'name': 'Laura M Chiang, MD', 'role': 'CONTACT', 'email': 'laura.m.chiang@hitchcock.org', 'phone': '6036500360'}, {'name': 'Laura M Chiang, MD', 'role': 'CONTACT', 'email': 'laura.m.chiang@hitchcock.org', 'phone': '6036505922'}], 'overallOfficials': [{'name': 'Laura M Chiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology at the Geisel School of Medicine, Co-medical Director of the Surgical Intensive Care Unit', 'investigatorFullName': 'Laura M. Chiang', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}