Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 5:14 AM
Study NCT ID:
NCT05410106
Status:
UNKNOWN
Last Update Posted:
2024-03-25
First Post:
2022-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilator Aspiration With PneuX (PneuX vs Standard Care Feasibility RCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Due to the nature of the interventional device it is not possible to blind the care providers or outcome assessors to the intervention group. The trial participants will be unconscious/sedated for the duration of the period that the PneuX device or standard ETT is in place and therefore will be unaware of their allocation. Samples sent to the laboratory for analysis will be anonymised using individual deidentified numbers for each participant.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Feasibility, 2-arm, parallel, randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The recruitment rate will be assessed using the "screening and recruitment log" which will record the number of patients recruited each month and reasons for non-recruitment will be described'}], 'secondaryOutcomes': [{'measure': 'To assess the feasibility of delivering the study intervention', 'timeFrame': 'Duration of study treatment (typically 4-7 days)', 'description': 'Any issues experienced when using the study device at any point during the study will be recorded in the CRF, including device-related complications.'}, {'measure': 'Number of participants with a failed pepsin test', 'timeFrame': 'Duration of study treatment (typically 4-7 days)', 'description': 'Any issues such as failed sampling or failed testing will be recorded in case report form'}, {'measure': 'Number of participants with a positive pepsin tracheal aspirate sample using Peptest', 'timeFrame': 'Duration of study treatment (typically 4-7 days)', 'description': 'The proportion of tracheal aspirate samples which are positive for the presence of pepsin using the Peptest test'}, {'measure': 'Volume of sub-glottic aspirates', 'timeFrame': 'Duration of study treatment (typically 4-7 days)', 'description': 'The volume of the sub-glottic aspirates will be measured every 24 hours'}, {'measure': 'Rate of tracheobronchial colonization', 'timeFrame': 'Duration of study treatment (typically 4-7 days)', 'description': 'Tracheobronchial colonization (no. colony forming units/ml) present in sputum samples will be measured by culture on days 3 and 7'}, {'measure': 'Proportion of patients who require antibiotics', 'timeFrame': '28 days', 'description': 'The following will be assessed: antibiotic prescribed, indication for use, number of days administered'}, {'measure': 'Rate of Ventilator Associated Pneumonia (VAP)', 'timeFrame': '28 days', 'description': 'Number of patients with VAP diagnosis. Clinical Pulmonary Infection Score (CPIS) used to predict VAP. CPIS \\>6 will be used to define confirmation of VAP. Measured daily after 48 hours of intubation'}, {'measure': 'Time spent on the ventilator', 'timeFrame': 'Duration of study treatment (typically 4-7 days)', 'description': 'Days spent with mechanical ventilation in ICU (from time/date of intubation to time/date of extubation or 28 days)'}, {'measure': 'Number of days spent in ICU and hospital', 'timeFrame': '28 days', 'description': 'Length of stay in ICU and length of stay in hospital measured in days from ventilation'}, {'measure': 'Rate of in-hospital mortality', 'timeFrame': '28 days', 'description': 'Number of patients who die in hospital up to 28 days after entry into ICU'}, {'measure': 'Rate of compliance with measuring and documenting cuff pressure', 'timeFrame': 'Duration of study treatment (typically 4-7 days)', 'description': 'Documentation of cuff pressures in both arms of study. Cuff pressure in standard care will be measured every 12 hours. Assessment of intervention arm will have documentation that pressure has been maintained hourly either via the continual cuff pressure monitor or manually.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventilator Associated Pneumonia', 'endotracheal tube', 'Aspiration'], 'conditions': ['Ventilator Associated Pneumonia', 'Aspiration', 'Infections', 'Ventilator Lung']}, 'descriptionModule': {'briefSummary': 'This is a single centre, open-label, feasibility randomised controlled trial. The study aims to assess the feasibility of conducting an RCT to compare the PneuX ETT with standard care in hospitalised patients requiring mechanical ventilation. The patient population for this study are those who are experiencing critical illness requiring intubation and ventilatory support. Patients will be randomised in equal proportions into one of 2 arms: to be intubated using a Venner PneuX Endotracheal Tube (ETT) or using the standard tube. For this feasibility study, a total of 50 patients will be randomised into two groups (25 in each). All patients will be recruited at a single site (University Hospital of Wales, part of Cardiff \\& Vale UHB). The study will investigate several feasibility measures including recruitment, delivery of the intervention (including device-related adverse events), acceptability and adherence to the intervention and sampling, use of Peptest to measure microaspiration events, rate of pepsin positive samples, rate of tracheobronchial colonisation, volume of sub-glottic aspirate, rate of VAP, length of ICU and hospital stay, demonstrate the validity of study documentation and provide preliminary data for 50 patients. The data will inform the pilot and main phase of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old (no upper age)\n* Patient required endotracheal intubation\n* Expect to remain intubated for 24 hours post randomisation\n\nExclusion Criteria:\n\n* The person intubating the patient assesses that the patient has already aspirated.\n* GCS 7 or less on presentation to hospital\n* Patient is pregnant\n* Patient has tracheostomy\n* Patient has gastrectomy\n* Patients who have been intubated prior to arrival at hospital\n* Patients who are already endotracheally intubated and require a tube change.'}, 'identificationModule': {'nctId': 'NCT05410106', 'acronym': 'VAP-X', 'briefTitle': 'Ventilator Aspiration With PneuX (PneuX vs Standard Care Feasibility RCT)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cardiff and Vale University Health Board'}, 'officialTitle': 'A Single Centre, Open-label, Feasibility Randomised Controlled Trial to Evaluate Gastric Microaspiration in Critically Ill Patients Intubated Using the Venner PneuX System Compared to Standard of Care Using Pepsin Biomarker (VAP-X)', 'orgStudyIdInfo': {'id': '21/NOV/8290'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PneuX endotracheal tube', 'description': 'Patients will be intubated using the PneuX endotracheal tube system', 'interventionNames': ['Device: PneuX Endotracheal Tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Patients will be intubated using standard endotracheal tube (Taperguard, Covidien).', 'interventionNames': ['Device: Standard care (Taperguard, Covidien)']}], 'interventions': [{'name': 'PneuX Endotracheal Tube', 'type': 'DEVICE', 'otherNames': ['Venner PneuX System'], 'description': 'The PneuX Endotracheal Tube is a CE marked device produced by Venner. The purpose of this product is to provide invasive ventilation for patients in the ICU. The defining features of the intervention treatment are the multi-modal approach to prevent microaspiration during long term ventilation.', 'armGroupLabels': ['PneuX endotracheal tube']}, {'name': 'Standard care (Taperguard, Covidien)', 'type': 'DEVICE', 'description': 'Standard care is to intubate patient using the Taperguard endotracheal tube (ETT). The Taperguard ETT is designed with a tracheal shaped cuff made of PVC. This has a single lumen subglottic port.', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF14 4XW', 'city': 'Cardiff', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jade Cole', 'role': 'CONTACT', 'email': 'Jade.Cole@wales.nhs.uk', 'phone': '029 21 843608'}], 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'centralContacts': [{'name': 'Judith White', 'role': 'CONTACT', 'email': 'judith.white3@wales.nhs.uk', 'phone': '02921844771'}, {'name': 'Rhys Morris', 'role': 'CONTACT', 'email': 'Rhys.Morris@wales.nhs.uk', 'phone': '0292144772'}], 'overallOfficials': [{'name': 'Matthew Wise', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiff and Vale University Health Board'}, {'name': 'Matthew Wise', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiff and Vale University Health Board'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff and Vale University Health Board', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Cardiff University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}