Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-06 @ 12:29 PM
Study NCT ID:
NCT03398733
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2018-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A total of 200 patients with rheumatic valvular heart disease waiting for heart valve replacement were screened for obstructive sleep apnea (OSA). Of them, 30 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (15:15 patients).The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-23', 'studyFirstSubmitDate': '2018-01-01', 'studyFirstSubmitQcDate': '2018-01-06', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'apnea-hypopnea index (AHI)', 'timeFrame': '2 weeks,depends on length of hospital stay', 'description': 'The changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.'}, {'measure': 'duration of ICU stay', 'timeFrame': "3 days, depends on the patient's recovery", 'description': 'Postoperative duration of ICU stay was compared between CPAP and non-CPAP patients.'}, {'measure': 'length of mechanical ventilation', 'timeFrame': "1 day, depends on the patient's recovery", 'description': 'Postoperative length of mechanical ventilation was compared between CPAP and non-CPAP patients.'}], 'secondaryOutcomes': [{'measure': 'mean and lowest SPO2', 'timeFrame': '2 weeks,depends on length of hospital stay', 'description': 'The changes of mean and lowest SPO2 pre- and post-operative were compared between CPAP and non-CPAP patients'}, {'measure': 'pacemaker use', 'timeFrame': "3 days, depends on the patient's recovery", 'description': 'Postoperative pacemaker use was compared between CPAP and non-CPAP patients.'}, {'measure': 'complicated infection and reintubation', 'timeFrame': "3 days, depends on the patient's recovery", 'description': 'Postoperative complicated infection and reintubation were compared between CPAP and non-CPAP patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'heart valve replacement', 'CPAP treatment'], 'conditions': ['Rheumatic Valvular Heart Disease', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '27448416', 'type': 'BACKGROUND', 'citation': 'Ding N, Ni BQ, Wang H, Ding WX, Xue R, Lin W, Kai Z, Zhang SJ, Zhang XL. Obstructive Sleep Apnea Increases the Perioperative Risk of Cardiac Valve Replacement Surgery: A Prospective Single-Center Study. J Clin Sleep Med. 2016 Oct 15;12(10):1331-1337. doi: 10.5664/jcsm.6182.'}, {'pmid': '37342775', 'type': 'DERIVED', 'citation': 'Su M, Lin W, Xu Q, Ni B, Zhang X, Zhang S, Ding N. Impact of 1-week preoperative auto-CPAP treatment on postoperative outcomes in patients undergoing heart valve replacement surgery: a prospective randomized controlled trial. Front Neurol. 2023 Jun 5;14:1152168. doi: 10.3389/fneur.2023.1152168. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of OSA (Obstructive sleep apneaļ¼OSA) is 2%-4% in general population and 16%-47% in surgical-heart failure patients. Our previous study found that OSA was associated with the increasing incidence of perioperative adverse events.The continuous positive airway pressure (CPAP), as the standard treatment for OSA, is extensively applied clinically. The previous study reported that postoperative AHI was reduced and SPO2 was increased by CPAP treatment. However, whether CPAP treatment can improve OSA postoperative and related adverse events or not in patients with rheumatic valvular heart diseases (RVHD) were not reported.The purpose of this study is to observe the effective of preoperative CPAP on postoperative sleep parameters and adverse events, such as AHI changes, duration of ICU stay and duration of mechanical ventilation.', 'detailedDescription': 'Between December 1, 2017 and June 30 2019, 200 patients with chronic heart failure caused by rheumatic valvular heart disease waiting for heart valve replacement in Department of Cardiovascular Surgery were screened for obstructive sleep apnea (OSA) by full-night polysomnography (PSG). Of them, 30 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (15:15).\n\nThe CPAP treatment group received both baseline and CPAP treatment. The full-night CPAP treatment was conducted from 21:00 pm to 6:00 am for 7 days preoperatively. The non-CPAP treatment group received baseline treatment.\n\nPreoperative Sleep parameters (AHI, mean and lowest SPO2) and clinical evaluations including NYHA class, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test were recorded.\n\nOperation related parameters such as duration of operation, duration of cardiopulmonary bypass and bleeding volume were recorded.\n\nPostoperative adverse events such as duration of ICU stay, postoperative duration of mechanical ventilation, pacemaker use, complicated infection and reintubation are recorded.\n\nA PSG was re-examined before discharge from hospital. The changes of AHI, mean and lowest SPO2 between pre- and post-operative PSG parameters were calculated.\n\nThe operation related parameters, postoperative adverse events and the changes of sleep parameters were compared between CPAP and non-CPAP patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged 18-75 years.\n2. Patients with rheumatic valvular heart disease.\n3. Patients combined with obstructive sleep apnea (apnea-hypopnea index \\>=5/h).\n4. Received heart valve replacement surgery.\n5. The enrolled patients having received patients' informed consent.\n\nExclusion Criteria:\n\n1. History of stroke or clinical signs of peripheral or central nervous system disorders.\n2. History of Chronic obstructive pulmonary disease or asthma.\n3. Enrolment in another clinical study."}, 'identificationModule': {'nctId': 'NCT03398733', 'acronym': 'CPAP', 'briefTitle': 'CPAP Treatment and Postoperative Outcomes in Patients With Rheumatic Valvular Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Preoperative CPAP Treatment on Perioperative Outcomes in Rheumatic Valvular Heart Disease Patients With OSA', 'orgStudyIdInfo': {'id': '2017-SR-040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'continuous positive airway pressure', 'description': 'The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively.', 'interventionNames': ['Device: continuous positive airway pressure']}], 'interventions': [{'name': 'continuous positive airway pressure', 'type': 'DEVICE', 'description': 'The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.', 'armGroupLabels': ['continuous positive airway pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ning Ding, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data will not be shared. The informed consent will be ansigned before enrolled in the study and ensured to keep personal information confidential.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ning Ding', 'investigatorAffiliation': 'Nanjing Medical University'}}}}