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Completed

NCT Number: NCT02515617

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

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.

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Key information

Conditions

Ventilator-associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU André Vésale ,, Montigny-le-Tilleul, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal tubes not allowing SSD

Device

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

Endotracheal tubes allowing SSD

Device

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.

Primary outcomes

  1. Incremental cost-utility ratio

    Time frame: 1 year after ICU admission

    Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation

Secondary outcomes

  1. Incremental cost-effectiveness ratio

    Time frame: 1 year after ICU admission

    Incremental cost to gain an additional patient free of adjudicated VAP

  2. Incremental cost-utility ratio (subgroup analysis)

    Time frame: 1 year after ICU admission

    Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD in considering patients alive at the ICU discharge

  3. Incremental cost-effectiveness ratio

    Time frame: 1 year after ICU admission

    Incremental cost to gain an additional life-year

  4. Budget impact analysis

    Time frame: 5 years

  5. Microbiologically-confirmed VAP incidence

    Time frame: 90 days after the start of invasive mechanical ventilation

  6. Microbiologically-confirmed VAP density of incidence

    Time frame: 90 days after the start of invasive mechanical ventilation

  7. Defined Daily Dose of antibiotics consumption

    Time frame: Until discharge from ICU, an expected average of 12 days

  8. Ventilator-associated Conditions incidence

    Time frame: 90 days after the start of invasive mechanical ventilation

  9. Ventilator-associated Conditions density of incidence

    Time frame: 90 days after the start of invasive mechanical ventilation

  10. Infection related Ventilator-associated Conditions incidence

    Time frame: 90 days after the start of invasive mechanical ventilation

  11. Duration of invasive mechanical ventilation

    Time frame: Until weaning of mechanical ventilation, an expected average of 10 days

  12. Ventilator-free days

    Time frame: 90 days after the start of invasive mechanical ventilation

  13. ICU length of stay

    Time frame: Until discharge from ICU, an expected average of 12 days

  14. Hospital length of stay

    Time frame: Until discharge from hospital, an expected average of 20 days

  15. ICU mortality

    Time frame: Until discharge from ICU, an expected average of 12 days

  16. 90-days mortality

    Time frame: 90 days after ICU admission

  17. 180-days mortality

    Time frame: 180 days after ICU admission

  18. 1 year mortality

    Time frame: 1 year after ICU admission

  19. Post-extubation laryngo-tracheal dyspnea incidence

    Time frame: Until weaning of mechanical ventilation,, an expected average of 10 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Collaborators

  • Ministry of Health, France
  • URC Eco Ile de France
  • University Hospital, Tours

Registry information

Official study title

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

Acronym: DEMETER

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2015
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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