Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 6:33 AM
Study NCT ID:
NCT07022704
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxapram Administration on Diaphragmatic Excursion in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease Undergoing Spontaneous Breathing Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004315', 'term': 'Doxapram'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-22', 'studyFirstSubmitDate': '2025-06-07', 'studyFirstSubmitQcDate': '2025-06-07', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Diaphragmatic excursion in mm', 'timeFrame': 'before and 10 minutes after doxappram'}], 'secondaryOutcomes': [{'measure': 'Arterial blood gases', 'timeFrame': 'before and 10 minutes after doxapram'}, {'measure': 'Respiratory rate', 'timeFrame': 'before and 10 minutes after doxapram'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Doxapram', 'Diaphragmatic excursion'], 'conditions': ['COPD', 'Mechanical Ventilation', 'Weaning From Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '33940248', 'type': 'BACKGROUND', 'citation': 'Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available.'}, {'pmid': '1600786', 'type': 'BACKGROUND', 'citation': 'Pourriat JL, Baud M, Lamberto C, Fosse JP, Cupa M. Effects of doxapram on hypercapnic response during weaning from mechanical ventilation in COPD patients. Chest. 1992 Jun;101(6):1639-43. doi: 10.1378/chest.101.6.1639.'}, {'pmid': '24527224', 'type': 'BACKGROUND', 'citation': 'Oikawa S, Nomura H, Nishio M, Nagata R, Hata T. Doxapram hydrochloride aggravates adrenaline-induced arrhythmias accompanied by bidirectional ventricular tachycardia. ISRN Cardiol. 2014 Jan 9;2014:212045. doi: 10.1155/2014/212045. eCollection 2014.'}, {'pmid': '33514664', 'type': 'BACKGROUND', 'citation': 'Rutka M, Palac M, Linek P. Diaphragmatic Mobility Loss in Subjects With Moderate to Very Severe COPD May Improve After In-Patient Pulmonary Rehabilitation. Respir Care. 2021 Feb;66(2):354. doi: 10.4187/respcare.08687. No abstract available.'}, {'pmid': '26392767', 'type': 'BACKGROUND', 'citation': 'Scheibe N, Sosnowski N, Pinkhasik A, Vonderbank S, Bastian A. Sonographic evaluation of diaphragmatic dysfunction in COPD patients. Int J Chron Obstruct Pulmon Dis. 2015 Sep 11;10:1925-30. doi: 10.2147/COPD.S85659. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Researchers aim to evaluate the impact of doxapram administration on diaphragmatic excursion in chronic obstructive pulmonary disease (COPD) patients undergoing spontaneous breathing trial', 'detailedDescription': 'doxapram will be administered intravenously (IV) during spontaneous breathing trial. diaphragmatic excursion will be evaluated by an expert in respiratory muscle ultrasound'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic obstructive pulmonary diseases undergoing breathing trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate to severe chronic obstructive pulmonary disease undergoing spontaneous breathing trial\n\nExclusion Criteria:\n\n* Refusal Allergy to doxapram neuromuscular disorders inability to evaluate the diaphragm'}, 'identificationModule': {'nctId': 'NCT07022704', 'briefTitle': 'Doxapram Administration on Diaphragmatic Excursion in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease Undergoing Spontaneous Breathing Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Influence of Doxapram Administration on Diaphragmatic Excursion in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease Undergoing Spontaneous Breathing Trial: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Doxapram in COPD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Doxapram', 'description': 'All patients will receive doxapram during spontaneous breathing trial', 'interventionNames': ['Drug: Doxapram']}], 'interventions': [{'name': 'Doxapram', 'type': 'DRUG', 'description': 'Doxapram will be given as 1.5 mg/kg will be given 10 minutes after the initiation of SBT', 'armGroupLabels': ['Doxapram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6890', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Cairo University', 'role': 'CONTACT', 'email': 'kasralainirec@gmail.com', 'phone': '01007174836'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mina Helmy, MD', 'role': 'CONTACT', 'email': 'dr_mina20002010@yahoo.com', 'phone': '+201007174836'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data regarding this research will be available from the corresponding author upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and critical care', 'investigatorFullName': 'Mina Adolf Helmy', 'investigatorAffiliation': 'Cairo University'}}}}