Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT05670093
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2022-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neural Pressure Support, Synchrony and Respiratory Muscle Unloading
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Interventional prospective study. Each participant is ventilated both on PS and NPS at 3 different support levels.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2022-11-19', 'studyFirstSubmitQcDate': '2023-01-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-ventilator asynchronies', 'timeFrame': '20 minutes ventilatory traces recording', 'description': 'quantification of asynchronies by the use of the Edi catheter'}], 'secondaryOutcomes': [{'measure': 'respiratory muscle unloading', 'timeFrame': '20 minutes ventilatory traces recording', 'description': 'quantification of muscle unloading by use of Pes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'In this study patients who are intubated and on ventilator for more than 24h will be ventilated at three different level of support in Pressure Support and Neural Pressure Support to study patient-ventilator synchrony and muscle unloading.', 'detailedDescription': 'This study is an interventional randomized crossover study in intubated and mechanically ventilated patients for more than 24h. Eligible patients from whom informed consent is obtained and Pes and Edi catheter are successfully positioned are enrolled in the study. Patients will be ventilated in Pressure Support and Neural Pressure Support at three different level of assist (baseline, 50% and 150% of baseline respectively) in randomized order. Ventilator curves will be recorded and bloodgas obtained at the end of each study step, each lasting 20min.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients intubated for more than 24 hours in the weaning phase from the ventilator.\n\nExclusion Criteria:\n\n* bleeding disorders (PK INR\\>1,5 or APTT\\>50s or platelet count \\<50000/µL)\n* unstable circulation (requiring high vasopressor dose, for example Noradrenalin \\>0,2µg/kg/min)\n* severe lung disease (PFI ≤ 13,3 kPa)\n* fever\\> 38,5°C\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT05670093', 'acronym': 'NPS', 'briefTitle': 'Neural Pressure Support, Synchrony and Respiratory Muscle Unloading', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Neural Pressure Support, a Randomized Crossover Trial', 'orgStudyIdInfo': {'id': 'k 2021-5369'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neural Pressure Support', 'description': 'Patients will be ventilated in Pressure Support and Neural Pressure Support at 3 different levels of support in randomized order', 'interventionNames': ['Device: Neural Pressure Support (mode of mechanical ventilation)']}], 'interventions': [{'name': 'Neural Pressure Support (mode of mechanical ventilation)', 'type': 'DEVICE', 'description': 'Nasogastric tube will be removed and replaced by a Esophageal catheter and Electrical Diaphragm activity catheter and mechanical ventilation in mode Neural Pressure Support', 'armGroupLabels': ['Neural Pressure Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Solna', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Francesca Campoccia Jalde, MD, PhD', 'role': 'CONTACT', 'email': 'francesca.campoccia-jalde@regionstockholm.se', 'phone': '+46703947741'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}], 'centralContacts': [{'name': 'Campoccia Jalde', 'role': 'CONTACT', 'email': 'francesca.campoccia-jalde@regionstockholm.se', 'phone': '+46703947741'}, {'name': 'Karolinska University Hospital', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Francesca Campoccia Jalde', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Francesca Campoccia Jalde, MD, PhD', 'investigatorFullName': 'Francesca Campoccia Jalde', 'investigatorAffiliation': 'Karolinska Institutet'}}}}