Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia

Ventilator-associated Pneumonia Clinical Trial

Official title:

Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585180
• Other study ID #: CHD 052-15
• 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

Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study. This ancillary study will be performed in 14 centers participating to the DEMETER study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• 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 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)

Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.	For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.	Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.	For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the tracheal secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the tracheal secretions will be considered as the same than the one involved in VAP if these 2 same microorganisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last tracheal secretions samples, if available, obtained before the VAP occurrence will be taking account.	Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP	Proportion of VAP for whom the probabilistic antibiotherapy used during the trial appeared to be empirically active	Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance	Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the subglottic secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).	Until weaning of mechanical ventilation, an expected average of 10 days
Secondary	Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance	Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the tracheal secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).	Until weaning of mechanical ventilation, an expected average of 10 days