Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-25 @ 5:48 PM
Study NCT ID:
NCT02169193
Status:
WITHDRAWN
Last Update Posted:
2015-12-04
First Post:
2014-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C512413', 'term': 'nanocis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of pepsin levels ≥200 ng / ml', 'timeFrame': 'from the start to 6 hours after beginning of 99m technetium labelled enteral feeding', 'description': 'Sensibility and sensitivity of Pepsin for the diagnosis of microaspiration will be determined with regard to 99m technetium (gold standard).'}], 'secondaryOutcomes': [{'measure': 'likelihood ratio of pepsin of microregurgitation', 'timeFrame': 'from the start to 6 hours after beginning of 99m technetium labelled enteral feeding', 'description': 'Sensibility and sensitivity of Pepsin for the diagnosis of microregurgitation will be determined with regard to 99m technetium.'}, {'measure': 'likelihood ratio of pepsin of microaspiration', 'timeFrame': 'from the start to 6 hours after beginning of 99m technetium labelled enteral feeding', 'description': 'positive and negative predictive values, positive and negative likelihood ratio of pepsin for the diagnosis of microaspiration compared to the 99m technetium (gold standard)'}, {'measure': 'Youden Index', 'timeFrame': 'from the start to 6 hours after beginning of 99m technetium labelled enteral feeding', 'description': 'Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)'}, {'measure': 'ROC curve', 'timeFrame': 'from the start to 6 hours after beginning of 99m technetium labelled enteral feeding', 'description': 'Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['microaspiration', 'mechanical ventilation', 'enteral feeding', '99m technetium', 'pepsin'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.', 'detailedDescription': 'Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. We hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> or = 18 years\n* hospitalised in ICU\n* tracheal intubation using a polyvinyl chloride tube and mechanical ventilation\n* predictable mechanical ventilation \\> or = 6 hours after inclusion\n* enteral nutrition by a nasogastric tube\n\nExclusion Criteria:\n\n* refuse to participate to the study\n* no informed consent\n* pregnant\n* contra-indication for enteral nutrition\n* tracheotomy\n* intubation or re-intubation done in 6 hours preceding the inclusion'}, 'identificationModule': {'nctId': 'NCT02169193', 'briefTitle': 'Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium', 'orgStudyIdInfo': {'id': '2011_09'}, 'secondaryIdInfos': [{'id': '2011-A0140932', 'type': 'OTHER', 'domain': 'ID-RDB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '99mTc-Rhenium Sulfide Nanocolloid', 'description': '99mTc-Rhenium Sulfide Nanocolloid', 'interventionNames': ['Radiation: 99mTc-Rhenium Sulfide Nanocolloid']}], 'interventions': [{'name': '99mTc-Rhenium Sulfide Nanocolloid', 'type': 'RADIATION', 'otherNames': ['NanoCis'], 'description': '12 MBq of NanoCis added to 500 ml of enteral feeding', 'armGroupLabels': ['99mTc-Rhenium Sulfide Nanocolloid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'ICU, Calmette Hospital, University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Saad Nseir, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ Hosp of Lille, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}