Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-04 @ 7:44 PM
Study NCT ID:
NCT06805760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation Strategies Impact on Oxygenation and Postoperative Pulmonary Complications in Lung Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oxygen saturation', 'timeFrame': 'One week postoperative'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Surgery']}, 'descriptionModule': {'briefSummary': "The purpose of this clinical trial was to understand the effects of variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), pressure-controlled ventilation (PCV), and open surgery (Open Surgery). controlled ventilation (C-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) for open surgery, video-assisted thoracoscopic surgery, and segmental lung resection. VATS), segmentectomy (Segmentectomy), lobectomy (Lobectomy), and pneumonectomy (Pneumonectomy) on oxygen saturation and pulmonary complications, and length of hospitalization.\n\nThe main question it aims to answer is: variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV).Does it decrease patient oxygen saturation, and does it increase pulmonary complications, length of hospitalization? Researchers compared variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to compare them to see which mode of ventilation has the least physiologic disruption for the patient.\n\nParticipants will:\n\nSelect the appropriate surgical procedure according to the condition and be randomized to variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume- controlled ventilation (C-VCV), pressure-controlled ventilation (PCV), and were checked after surgery.\n\nPatients' oxygen saturation, pulmonary complications, length of hospitalization were recorded"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring any of open surgery, television-assisted thoracoscopic surgery (VATS), segmental lung resection (Segmentectomy), lobectomy, and total lung resection (Pneumonectomy).\n* Patients who are able to receive any of the ventilation modes of controlled ventilation (C - VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C - VCV), pressure-controlled ventilation (PCV), and variable tidal volume ventilation (V - VCV).\n\nExclusion Criteria:\n\n* Patients with severe cardiac, hepatic, renal, and other vital organ dysfunction\n* Patients with mental illness or cognitive disorders that prevent them from understanding the study and cooperating with the study process.\n* Patients with hematologic disorders\n* Pregnant or breastfeeding females'}, 'identificationModule': {'nctId': 'NCT06805760', 'briefTitle': 'Ventilation Strategies Impact on Oxygenation and Postoperative Pulmonary Complications in Lung Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Inner Mongolia Baogang Hospital'}, 'officialTitle': 'Ventilation Strategies Impact on Oxygenation and Postoperative Pulmonary Complications in Lung Surgery Patients: a Prospective, Randomized, Triple-Blind Trial', 'orgStudyIdInfo': {'id': '2024-MER-313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V-VCV Group', 'description': 'The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\\_max) and minimum tidal volume (Vt\\_min) were set at 10-20% of the basal tidal volume (Vt\\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.', 'interventionNames': ['Other: variable tidal volume ventilation (V-VCV)']}, {'type': 'EXPERIMENTAL', 'label': 'PRVC Group', 'description': 'The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt\\_max) and the minimum tidal volume (Vt\\_min) was set at 10-20% of the base tidal volume (Vt\\_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%.', 'interventionNames': ['Other: pressure-regulated volume-controlled ventilation (PRVC)']}, {'type': 'EXPERIMENTAL', 'label': 'C-VCV Group', 'description': 'The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\\_max) and minimum tidal volume (Vt\\_min) were set at 10-20% of the basal tidal volume (Vt\\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.', 'interventionNames': ['Other: conventional volume-controlled ventilation (C-VCV)']}, {'type': 'EXPERIMENTAL', 'label': 'PCV Group', 'description': 'The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%.', 'interventionNames': ['Other: pressure-controlled ventilation (PCV)']}], 'interventions': [{'name': 'variable tidal volume ventilation (V-VCV)', 'type': 'OTHER', 'description': 'The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\\_max) and minimum tidal volume (Vt\\_min) were set at 10-20% of the basal tidal volume (Vt\\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.', 'armGroupLabels': ['V-VCV Group']}, {'name': 'pressure-regulated volume-controlled ventilation (PRVC)', 'type': 'OTHER', 'description': 'The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt\\_max) and the minimum tidal volume (Vt\\_min) was set at 10-20% of the base tidal volume (Vt\\_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%.', 'armGroupLabels': ['PRVC Group']}, {'name': 'conventional volume-controlled ventilation (C-VCV)', 'type': 'OTHER', 'description': 'The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\\_max) and minimum tidal volume (Vt\\_min) were set at 10-20% of the basal tidal volume (Vt\\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.', 'armGroupLabels': ['C-VCV Group']}, {'name': 'pressure-controlled ventilation (PCV)', 'type': 'OTHER', 'description': 'The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%.', 'armGroupLabels': ['PCV Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '014010', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'contacts': [{'name': 'Xiangyu XY Wang, Undergraduate', 'role': 'CONTACT', 'email': 'KevinDuan0901@gmail.com', 'phone': '+86 0472 5992830'}], 'facility': 'Inner Mongolia Baogang Hospital', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}], 'centralContacts': [{'name': "Xiaguang XG Duan, Master's degree", 'role': 'CONTACT', 'email': 'alonlord2023@gmail.com', 'phone': '+86 13314720012'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'January 2026-January 2036', 'ipdSharing': 'YES', 'accessCriteria': 'A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inner Mongolia Baogang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}