Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)

Study Overview
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Brief Summary
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In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the basic practices to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.

Official Title
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Drainage of Subglottic Secretions and Prevention of Ventilator-associated Pneumonia in Intensive carE Units: Medico-Economic Study With a Randomized clusTer and crossovER Design: DEMETER Study

Conditions
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Ventilator-associated Pneumonia

Intervention / Treatment
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* Device: Endotracheal tubes not allowing SSD
* Device: Endotracheal tubes allowing SSD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial Information delivered Exclusion Criteria: Previous inclusion in the study Patients moribund at the ICU admission Pregnant, parturient or breast-feeding woman Patient hospitalized without consent and/or deprived of liberty by court's decision Patient under guardianship or curators Lack of social insurance Concomitant inclusion in a trial on VAP prevention Patient with no comprehension of the French language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Period with endotracheal tubes not allowing SSD<br>During this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage | Device: Endotracheal tubes not allowing SSD<br>* In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure<br>|
| Experimental: Period with endotracheal tubes allowing SSD<br>During this period, patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage | Device: Endotracheal tubes allowing SSD<br>* In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure. In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-utility ratio | Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation | 1 year after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-effectiveness ratio | Incremental cost to gain an additional patient free of adjudicated VAP | 1 year after ICU admission | 
| Incremental cost-utility ratio (subgroup analysis) | Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD in considering patients alive at the ICU discharge | 1 year after ICU admission | 
| Incremental cost-effectiveness ratio | Incremental cost to gain an additional life-year | 1 year after ICU admission | 
| Budget impact analysis |  | 5 years | 
| Microbiologically-confirmed VAP incidence |  | 90 days after the start of invasive mechanical ventilation | 
| Microbiologically-confirmed VAP density of incidence |  | 90 days after the start of invasive mechanical ventilation | 
| Defined Daily Dose of antibiotics consumption |  | Until discharge from ICU, an expected average of 12 days | 
| Ventilator-associated Conditions incidence |  | 90 days after the start of invasive mechanical ventilation | 
| Ventilator-associated Conditions density of incidence |  | 90 days after the start of invasive mechanical ventilation | 
| Infection related Ventilator-associated Conditions incidence |  | 90 days after the start of invasive mechanical ventilation | 
| Duration of invasive mechanical ventilation |  | Until weaning of mechanical ventilation, an expected average of 10 days | 
| Ventilator-free days |  | 90 days after the start of invasive mechanical ventilation | 
| ICU length of stay |  | Until discharge from ICU, an expected average of 12 days | 
| Hospital length of stay |  | Until discharge from hospital, an expected average of 20 days | 
| ICU mortality |  | Until discharge from ICU, an expected average of 12 days | 
| 90-days mortality |  | 90 days after ICU admission | 
| 180-days mortality |  | 180 days after ICU admission | 
| 1 year mortality |  | 1 year after ICU admission | 
| Post-extubation laryngo-tracheal dyspnea incidence |  | Until weaning of mechanical ventilation,, an expected average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critically ill patients, Ventilator-associated pneumonia, Subglottic-secretions drainage, Cost-utility analysis, Prevention