Infections Clinical Trial
Official title:
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)
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06055777 -
Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts
|
Phase 1 | |
| Recruiting |
NCT05578196 -
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
|
N/A | |
| Recruiting |
NCT05793983 -
S100A8/A9 and Innate Immunity in Liver Disease
|
||
| Active, not recruiting |
NCT05963269 -
The Effect of the Game on Students' Intramuscular Injection Skills
|
N/A | |
| Not yet recruiting |
NCT06026852 -
Validation of Betalactam ML Prediction Models - TDMAide
|
N/A | |
| Not yet recruiting |
NCT02222779 -
Quantification of Transition Metals
|
N/A | |
| Completed |
NCT01976234 -
Stored RBC Transfusion and Immonomodulation
|
N/A | |
| Completed |
NCT01530763 -
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
|
Phase 2/Phase 3 | |
| Completed |
NCT02345135 -
Susceptibility to Infections in Ataxia Telangiectasia
|
N/A | |
| Completed |
NCT01158560 -
A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections
|
Phase 3 | |
| Completed |
NCT01176786 -
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
|
N/A | |
| Active, not recruiting |
NCT05284097 -
Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study
|
Phase 2 | |
| Enrolling by invitation |
NCT06055712 -
Antibiotic Prophylaxis in Pediatric Open Fractures
|
Phase 4 | |
| Not yet recruiting |
NCT06402292 -
Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute
|
N/A | |
| Not yet recruiting |
NCT06338345 -
Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients
|
N/A | |
| Recruiting |
NCT06002685 -
Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention
|
N/A | |
| Completed |
NCT02802059 -
E. Coli Nissle 1917 - Suspension for Infection Prophylaxis
|
Phase 3 | |
| Completed |
NCT05289674 -
The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection
|
N/A | |
| Recruiting |
NCT05770765 -
Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases
|
||
| Completed |
NCT05389540 -
Rural South and Southeast Asia Household Health Survey
|