Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00190-47 | Other Identifier | Eudract CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hypothesis: NostenĀ® 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 NostenĀ® 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 NostenĀ® 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: NostenĀ® monitoring | Experimental | One experimental group with the control of the cuff pressure by NostenĀ® device |
|
| 2: Manual monitoring | Active Comparator | One control group with the manual monitoring of the cuff pressure and inflation of the balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NostenĀ® pressure control (it's not an antibiotic, but simple device) | Device | One experimental group with the control of the cuff pressure by NostenĀ® device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion) | To prove that the NostenĀ® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the tracheobronchial bacterial colonization assessed using the bacteriological examination of the tracheal aspiration (as long as the patient is intubated during 3 months after inclusion) | using the bacteriological examination of the tracheal aspiration during the intensive care hospitalization | up to 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno MEGARBANE, MD, PhD | Contact | (+33)1 49 95 64 91 | bruno.megarbane@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bruno MEGARBANE, MD, PhD | Assistance Publique - HƓpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de RƩanimation MƩdical et Toxicologique | Recruiting | Paris | 75010 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
| Manual pressure control | Other | One control group with the manual monitoring of the cuff pressure and inflation of the balloon |
|
| Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP) |
before obtaining microbiological results needed to affirm the Ventilator-Acquired Pneumonia (VAP) according to the criteria of the American Thoracic Society (3 months) |
| up to 3 months |
| Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months) | Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP) | up to 3 months |
| Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion) | Using NostenĀ® device | up to 3 months |
| Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months) | using the tracheal ischemia score [Touat L. Intensive Care Med 2014] | up to 3 months |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided