Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-20 @ 4:22 PM
Study NCT ID:
NCT06680895
Status:
RECRUITING
Last Update Posted:
2024-11-08
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FeNO Observation Study in ICU Patients With ARS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FeNO concentration', 'timeFrame': '1.5 year', 'description': 'Exhaled nitric oxide concentration of patients with different severity of respiratory failure in ICU'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Compare the Concentration of Exhaled Nitric Oxide in Patients With Different Severity of RF']}, 'descriptionModule': {'briefSummary': '1. Main Objective: To compare the concentration of exhaled nitric oxide in patients with different severity of respiratory failure in ICU.\n2. Secondary Purpose:\n\n 1. To observe the change of nitric oxide concentration in exhaled breath of patients with mechanical ventilation over time;\n 2. The relationship and differences between pulmonary ventilation blood flow levels in patients with different exhaled NO concentrations;\n 3. Reactivity of patients with different exhaled NO concentrations to inhaled nitric oxide therapy and the relationship between them.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients with advanced respiratory support', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients (≥18 years of age) with mechanical ventilation or advanced respiratory support in the ICU, regardless of gender;\n2. The expected mechanical ventilation time of tracheal intubation is more than 24 hours;\n3. The initial ventilator Settings of clinical routine were adopted: oxygen fraction (FIO2) = 50%, respiratory rate = 15/min, positive end-expiratory pressure (PEEP) = 5 cmH2O, tidal volume = 6-8 ml/kg ideal body weight (IBW), inspiration-exhalation ratio =1:2;\n4. Agree to participate in this experiment and sign the informed consent.\n\nExclusion Criteria:\n\n* 1.Use of any NO-containing drugs (such as nitroglycerin), anti-inflammatory drugs, or drugs or means that affect the airway diameter within 6 hours before the first FeNO measurement; 2. Participating in other clinical research projects; 3. Patients deemed unsuitable by the investigators.'}, 'identificationModule': {'nctId': 'NCT06680895', 'briefTitle': 'FeNO Observation Study in ICU Patients With ARS', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'An Observational Study of Fractional Exhaled Nitric Oxide Concentration in Patients With Advanced Respiratory Support', 'orgStudyIdInfo': {'id': 'ShanghaiZhongshanICU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FeNO Observation', 'type': 'OTHER', 'description': 'FeNO was observed and measured among patients with advanced respiratory support'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huan Wang, Master', 'role': 'CONTACT', 'email': 'wang.huan@zs-hospital.sh.cn', 'phone': '13472735075'}], 'facility': 'Shanghai Zhongshan hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huan Wang, Master', 'role': 'CONTACT', 'email': 'wang.huan@zs-hospital.sh.cn', 'phone': '13472735075'}], 'overallOfficials': [{'name': 'Ming Zhong, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}