Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation

Ventilator-associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583308
• Other study ID #: CHD 053-15
• Status: Completed
• Phase: N/A
• Start date: November 4, 2015
• Est. completion date: November 29, 2017

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 896
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Device:
• Endotracheal tubes not allowing SSD
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
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.

Locations

Country	Name	City	State
Belgium	CHU André Vésale	Montigny-le-Tilleul.
France	CH Annecy Genevois	Annecy
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	Centre Hospitalier Intercommunal des Portes de l'Oise	Beaumont-sur-Oise
France	Chd Vendee	La Roche sur Yon
France	CH Docteur Schaffner	Lens
France	CH de Montauban	Montauban
France	Centre Hospitalier Régional d'Orléans	Orleans
France	CHU Pointe-à-Pitre les Abymes	Pointe-à-Pitre
France	CHI Poissy Saint Germain	Poissy
France	Centre Hospitalier René Dubos	Pontoise
France	CH de Saint Nazaire	Saint Nazaire
France	CHU La Réunion, site de Saint Denis de la Réunion	Saint-Denis (Réunion)
France	CHU de Strasbourg Nouvel Hôpital Civil	Strasbourg
France	CHU Tours, site Bretonneau	Tours

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Ministry of Health, France, University Hospital, Tours

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (1)

Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.		Until weaning of mechanical ventilation, an expected average of 10 days