Mechanical Ventilation Clinical Trial
Official title:
Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload. The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.
Multicenter, controlled, prospective randomized open study with blinded assessment of the primary endpoint. Two groups are set up: one experimental group with the control of the cuff pressure by the Nosten® device versus one control group with the manual monitoring of the cuff pressure and inflation of the balloon. Inclusion: All orotracheally intubated patients for an expected period > 48 hours will be selected. Inclusion will be decided using an algorithm adapted to each center to limit the number of inclusion per month without any biases. The total number of required insclusion is 500, or 250 / group. This calculation is based on the assumption that a frequency of 25% of patients having at least one VAP in the reference strategy, ensuring a 80% power in the detection by Chi-2 test with a difference 10%. A bilateral risk of first species determined at 5% was considered. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05921656 -
Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube
|
||
| Recruiting |
NCT03941002 -
Continuous Evaluation of Diaphragm Function
|
N/A | |
| Withdrawn |
NCT04288076 -
The Brain and Lung Interaction (BALI) Study
|
N/A | |
| Completed |
NCT03031860 -
Semi-quantitative Cough Strength Score (SCSS)
|
N/A | |
| Completed |
NCT02312869 -
Local Assessment of Management of Burn Patients
|
N/A | |
| Completed |
NCT02545621 -
A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
|
||
| Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
| Completed |
NCT01204281 -
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
|
Phase 4 | |
| Terminated |
NCT01059929 -
Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
|
Phase 4 | |
| Completed |
NCT00824239 -
Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients
|
Phase 3 | |
| Completed |
NCT00529347 -
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern
|
Phase 1 | |
| Unknown status |
NCT00260676 -
Protective Ventilatory Strategy in Potential Organ Donors
|
Phase 3 | |
| Terminated |
NCT00205517 -
Sedation and Psychopharmacology in Critical Care
|
N/A | |
| Completed |
NCT03281785 -
Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.
|
N/A | |
| Recruiting |
NCT04110613 -
RCT: Early Feeding After PEG Placement
|
N/A | |
| Completed |
NCT04410783 -
The Emergency Department Sedation Pilot Trial
|
N/A | |
| Recruiting |
NCT04821453 -
NAVA vs. CMV Crossover in Severe BPD
|
N/A | |
| Completed |
NCT03930147 -
Ventilation With ASV Mode in Children
|
N/A | |
| Recruiting |
NCT05029167 -
REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study)
|
N/A | |
| Recruiting |
NCT04849039 -
Lung Microbiota and VAP Development (PULMIVAP)
|