Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT02490657
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2015-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation
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': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-19', 'studyFirstSubmitDate': '2015-06-15', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tei-index (tissue Doppler image-derived myocardial performance ) at lateral and septal', 'timeFrame': 'myocardial performance changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)', 'description': 'Tei-index (tissue Doppler image-derived myocardial performance ) at lateral and septal'}], 'primaryOutcomes': [{'measure': 'PaO2 /FiO2 ratio during one-lung ventilation', 'timeFrame': 'oxygenation changes from baseline (OLV), in 30 min after nebulizing iloprost or normal saline(ILO-30), in 60 min after nebulizing iloprost or normal saline(ILO-60), to after 20 min in postanaestheticcare unit(PACU)'}], 'secondaryOutcomes': [{'measure': 'biventricular diastolic function', 'timeFrame': 'biventricular diastolic function changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO)', 'description': "E/e' estimated by tissue Doppler index"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Video-assisted Thoracoscopic Surgery', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation, and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled iloprost has been researched in animal study, but not yet in human during one-lung ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air or PaO2 /FiO2 ratio\\< 150 mmHg after initiating one-lung ventilation. The primary outcome is pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of cardiac function including Tei-index during nebulizing iloprost. The investigators hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic obstructive pulmonary disease during one-lung ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chronic obstructive pulmonary disease was defined as FEV1/FVC ratio \\< 0.7 and an FEV 1 of 80% or less after inhalation bronchodilator : 1. Above 40 years of age.\n2. American Society of Anesthesiologists (ASA) Physical Status II, III.\n3. Preoperative SpO2 95 % or less at room air (spontaneous ventilation) or 4. PaO2 /FiO2 ratio\\< 150 mmHg after initiating one-lung ventilation\n\nExclusion Criteria:\n\n1. Severe functional liver or kidney disease\n2. Diagnosed HF (LV ejection fraction \\<50% , or wall motion abnormality)\n3. Arrhythmia or received treatment with antiarrythmic drug .\n4. Severe bradycardia(HR \\< 45 bpm) and AV block 6. pathologic esophageal lesion (esophageal stricture or varix ) 7. pregnancy 8. PaO2 /FiO2 ratio ≥ 150 mmHg after initiating one-lung ventilation'}, 'identificationModule': {'nctId': 'NCT02490657', 'briefTitle': 'Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2015-0283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iloprost group', 'interventionNames': ['Drug: Inhaled iloprost']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'interventionNames': ['Drug: normal saline (Saline 0.9%)']}], 'interventions': [{'name': 'Inhaled iloprost', 'type': 'DRUG', 'description': 'Nebulized agents (Iloprost or normal saline) were randomized by computer-generated randomization. The patients and anesthesiologist, who administered inhalation and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication, was the only person recognizing of the randomization code during trial.\n\nEnrolled patients were received 20 μg iloprost or placebo (norma saline). Iloprost was diluted in normal saline to obtain 2ml solution. Control group were inhaled comparable dose of normal saline. Iloprost or normal saline was inhaled through an ultrasonic nebulized system in inspiratory limb.', 'armGroupLabels': ['Iloprost group']}, {'name': 'normal saline (Saline 0.9%)', 'type': 'DRUG', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}