Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-30 @ 3:24 AM
Study NCT ID:
NCT05817968
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2023-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Solid State vs. Balloon Esophageal Catheter for Estimation of Pleural Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Method comparison study; participants serve as their own control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter.', 'timeFrame': '30 minutes', 'description': 'Absolute Pes value (in cmH2O) at end-expiration and at peak inspiration (based on flow recordings) will be recorded.'}, {'measure': 'Difference in relative Pes-derived parameters obtained by solid state catheter vs. balloon catheter.', 'timeFrame': '30 minutes', 'description': 'Relative Pes value (cmH2O) will be measured as the inspiratory amplitude in Pes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal manometry', 'Respiratory monitoring', 'Mechanical ventilation', 'Pleural pressure'], 'conditions': ['Respiratory Failure', 'Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '39871347', 'type': 'DERIVED', 'citation': 'van Oosten JP, Goedendorp N, Mousa A, Flink RC, Schaart R, Flinsenberg M, Somhorst P, Gommers DAMPJ, Heunks L, Jonkman AH. Solid-state esophageal pressure sensor for the estimation of pleural pressure: a bench and first-in-human validation study. Crit Care. 2025 Jan 27;29(1):47. doi: 10.1186/s13054-025-05279-w.'}]}, 'descriptionModule': {'briefSummary': 'Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid-state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.\n\nThis method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.', 'detailedDescription': "Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.\n\nThis method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.\n\nSubjects will receive a standard balloon esophageal catheter and a solid-state pressure catheter for simultaneous measurements of Pes. Study population will be post-surgical ICU patients. Measurements will be performed during clinical mechanical ventilation settings which include a first phase of passive controlled ventilation (patient is still sedated after surgery) as well a phase of partially-assisted ventilation where the patient's breathing effort has resumed and is assisted by the ventilator. During both phases, 10-15 minutes of tidal breathing will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Patient requiring mechanical ventilation at the ICU following cardiothoracic or abdominal surgery\n* Age ≥ 18 year\n\nExclusion Criteria:\n\n* Pregnancy\n* Upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)\n* Nasal bleeding within the last \\<2 weeks\n* Presence of pneumothorax\n* Use of anticoagulants that increase the risk of catheter insertion'}, 'identificationModule': {'nctId': 'NCT05817968', 'briefTitle': 'Solid State vs. Balloon Esophageal Catheter for Estimation of Pleural Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Comparison of a Solid State Versus Balloon Esophageal Catheter for Estimation of Pleural Pressure in Surgical ICU Patients', 'orgStudyIdInfo': {'id': 'MEC-2023-0119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esophageal manometry using a solid state sensor vs. balloon catheter', 'description': 'Placement of both a solid state and balloon esophageal pressure (Pes) catheter. Pes recordings of these catheters will be acquired simultaneously during both controlled mechanical ventilation and assisted mechanical ventilation, for 10-15 minutes per phase. Ventilator settings/protocol will be as per standard-of-care.', 'interventionNames': ['Device: intelligent Esophageal Pressure Catheter (iEPC)']}], 'interventions': [{'name': 'intelligent Esophageal Pressure Catheter (iEPC)', 'type': 'DEVICE', 'otherNames': ['Solid state esophageal pressure catheter, PulmoTech B.V.'], 'description': 'Placement of the iEPC nasogastric catheter with solid state sensor for esophageal manometry.\n\nComparator: Esophageal balloon catheter (NutriVent).', 'armGroupLabels': ['Esophageal manometry using a solid state sensor vs. balloon catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Annemijn Jonkman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pulmotech B.V.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Annemijn Jonkman', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}