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| ID | Type | Description | Link |
|---|---|---|---|
| ID RCB | Other Identifier | ANSM |
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This trial will study the impact of a combined strategy to prevent microaspiration of oropharyngeal secretions or gastric content using automated subglottic secretion drainage and/or continuous cuff pressure monitoring. These measures aim at preventing secretions of oropharyngeal or gastric origin from entering lower respiratory tracts of patients under invasive mechanical ventilation in intensive care units (ICU), referred to as microaspiration, in the hope of preventing ventilator-associated pneumonia, a condition associated with patient outcome worsening. Patients will be randomly assigned to one of four groups: a combined strategy group using both automated techniques, 2 groups using either one or the other automated technique, and a control group using standard of care. Microaspiration will be detected by measuring concentration of oropharyngeal (amylase) or gastric (pepsin) enzymes in tracheal aspirates.
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined strategy | Experimental | Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices |
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| Automated subglottic secretion drainage | Experimental | Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually. |
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| Automated continuous cuff pressure monitoring | Experimental | Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually. |
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| Control group | Active Comparator | Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined strategy | Procedure | Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of global abundant microaspiration | Microaspiration of oropharyngeal secretions will be detected by measuring amylase concentration levels in tracheal aspirates Microaspiration of gastric content will be detected by measuring pepsin concentration levels in tracheal aspirates Global abundant microaspiration will be defined by a proportion of at least 30% of tracheal aspirates with significant amylase and/or pepsin concentrations | 48 hours after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-associated pneumonia incidence | The incidence of ventilator-associated pneumonia (VAP) will be assessed using the 2005 IDSA/ATS guidelines. VAP will be suspected when a new or progressing chest X-ray infiltrate is associated to at least 2 criteria among: fever > 38 °C or < 35 °C, leukocytosis > 12 G/L or leukopenia < 4 G/L, purulent tracheal secretions. VAP will be confirmed when these criteria are associated to microbiological confirmation, with at least 105 CFU/mL in endotracheal aspirates or broncho-alveolar lavage. |
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Inclusion Criteria:
Adult patients (> 18 years-old) admitted to the ICU Mechanical ventilation duration expected to be > 48 h Intubated with a tracheal tube allowing subglottic secretion drainage
Exclusion Criteria:
Ongoing pregnancy Patients lacking health insurance Patients lacking legal capacity Moribund patients (expected to die in the first 24 h of ICU stay) Patients with specific oropharyngeal conditions (e.g. severe soft tissue infections of the neck, pharyngeal or laryngeal surgery, history of larynx or pharynx irratidation)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DEMONT G IDE | Contact | 00 33 3 20 44 44 95 | gregoire.demont@chru-lille.fr |
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A prospective, multicenter, controlled, randomized, open-label study with four balanced parallel groups.
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| Automated subglottic secretion drainage | Procedure | Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually. |
|
| Automated continuous cuff pressure monitoring | Procedure | Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually |
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| Control group | Procedure | Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously |
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| 28 days |
| Duration of mechanical ventilation | Duration of mechanical ventilation during ICU stay, censored at day 28 | 28 days |
| ICU length of stay | ICU length of stay, censored at day 28 | 28 days |
| Mortality | Mortality censored at day 28 | 28 days |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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