Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05950893
Status:
RECRUITING
Last Update Posted:
2024-07-25
First Post:
2023-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2023-07-01', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement of PMIvent and PMIref', 'timeFrame': '3 hours', 'description': 'The accuracy of PMIvent compared to PMIref was assessed by a Bland-Altman plot for each ventilator.'}], 'secondaryOutcomes': [{'measure': 'Correlation of inspiratory effort and PMIvent', 'timeFrame': '3 hours', 'description': 'The inspiratory effort is measured as the pressure generated by inspiratory muscles using esophageal pressure monitoring. This study selected Pmus and PTPes per minute as the reference for inspiratory effort.'}, {'measure': 'The predicted value of PMIvent for low/high effort', 'timeFrame': '3 hours', 'description': 'The target range for "high" inspiratory effort was defined as Pmus \\> 10 cmH2O and PTPes per minute \\> 200 cmH2O·s·min-1, and the target range for "low" inspiratory effort was defined as Pmus \\< 5 cmH2O and PTPes per minute \\< 50 cmH2O·s·min-1.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pressure support ventilation', 'inspiratory effort', 'inspiratory muscle pressure index'], 'conditions': ['Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': "It is critical to maintain a relatively normal inspiratory effort during pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort. The inspiratory muscle pressure index (PMI) can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain. Previous studies on PMI were based on physiological research and experimental conditions (PMIref), which require special pressure monitoring devices and software to collect and measure airway pressure. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). The overall aim of this study was to determine PMIvent's clinical feasibility and validity for accessing inspiratory effort during PSV.", 'detailedDescription': "The intensity of effort the respiratory system produces after receiving respiratory center drive is referred to as inspiratory effort. It is critical to maintain a relatively normal inspiratory effort during assist mechanical ventilation. During pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort.\n\nThe inspiratory muscle pressure index (PMI) is an indicator based on airway pressure (Paw), defined as the difference between plateau pressure (Pplat) and airway peak pressure (Ppeak). PMI can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with end-inspiratory muscle pressure (Pmus,ei) and esophageal pressure time product per breath (PTPes). Current studies have shown that PMI is an accurate indicator of inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain.\n\nPrevious studies on PMI were based on physiological research and experimental conditions, which require special pressure monitoring devices and software to collect and measure airway pressure. In this investigation, the standard measurement of PMI (PMIref) was the difference between Pplat at one cardiac cycle (0.5-1.2s) following end-inspiratory occlusion (EIO) and Ppeak at EIO. This measurement method can avoid the interference of cardiac artifacts on Paw to the greatest extent. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). When obtaining PMIvent, the operator could only select a relatively stationary Pplat by visual inspection, and the cardiac artifacts could not be avoided.\n\nSeveral additional issues need to be addressed when PMI is going to be used in clinical practice to monitor inspiratory effort in ventilated patients. Is PMI easy to obtain? Can PMIvent replace PMIref? What is the effect of different ventilators on PMIvent measurement? What is the relationship between PMIvent and inspiratory effort? Can PMIvent detect high/low effort? Therefore, the aims of this study were to explore the clinical acquisition rate of PMI, the agreement between PMIvent and PMIref, and the predicted value of PMIvent for inspiratory effort. The overall aim was to determine PMI's clinical feasibility and validity for accessing inspiratory effort during PSV."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode\n\nExclusion Criteria:\n\n1. age younger than 18 years old or older than 85 years\n2. known pregnancy and parturient\n3. chronic occlusive pulmonary diseases\n4. gastric, esophageal injury\n5. barotrauma\n6. diaphragm dysfunction\n7. intracranial hypertension and brain stem injury\n8. consciousness level decreased (RASS less than -2 scores)\n9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care.'}, 'identificationModule': {'nctId': 'NCT05950893', 'briefTitle': 'The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'The Clinical Feasibility and Validity of Simple Measurement of Inspiratory Muscle Pressure Index (PMIvent) to Access Inspiratory Effort During Pressure Support Ventilation', 'orgStudyIdInfo': {'id': 'KT2023-032-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.', 'interventionNames': ['Procedure: pressure support level']}], 'interventions': [{'name': 'pressure support level', 'type': 'PROCEDURE', 'description': 'Baseline ventilators were set by the principle of keeping VT/PBW at 6-8ml/kg and RR at 20-30 breaths/min and the decision of the responsible ICU physician. After then the fraction of inspired oxygen (FiO2), positive expiratory end pressure (PEEP), trigger sensitivity, and cycle-off criteria remain unchanged. Downward PS level titration was performed from 20 cmH2O to 2 cmH2O at a 2cm H2O interval. Every PS level was maintained for 20 minutes and then three end-inspiratory holdings (2-3seconds) and three end-expiratory holdings were performed. To avoid additional injury to the lung and diaphragm, the airway peak pressure (Ppeak) was limited to 30cmH2O.Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ran Gao, MD', 'role': 'CONTACT', 'email': '1205961482@qq.com', 'phone': '+8617647611107'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jian-Xin Zhou, MD', 'role': 'CONTACT', 'email': 'zhoujx.cn@icloud.com', 'phone': '8610 59978019'}, {'name': 'Ran Gao, MD', 'role': 'CONTACT', 'email': '1205961482@qq.com', 'phone': '+8617647611107'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jian-Xin Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian-Xin Zhou', 'investigatorAffiliation': 'Capital Medical University'}}}}