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NCT Number: NCT02583308

Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation

Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.

This ancillary study will be performed in 14 centers participating to the DEMETER study

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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 Intensive Care Unit 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. Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.

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

Secondary outcomes

  1. Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.

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

  2. Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.

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

  3. Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.

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

  4. Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.

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

  5. Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.

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

  6. Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.

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

  7. Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.

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

  8. Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

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

  9. Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

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

  10. Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

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

  11. Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

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

  12. Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

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

  13. Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

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

  14. Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

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

  15. Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.

    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
  • University Hospital, Tours

Registry information

Official study title

Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2015
Registry last updated
Mar 23, 2021

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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