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

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

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

Study Overview

• Status: Completed
• Conditions: Ventilator-associated Pneumonia
• Intervention / Treatment: Device: Endotracheal tubes not allowing SSD; Device: Endotracheal tubes allowing SSD

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Montigny-le-Tilleul., Belgium, 6110
    • CHU Andre VESALE
• France
  • Annecy, France, 74374
    • Ch Annecy Genevois
  • Argenteuil, France, 95100
    • Centre Hospitalier Victor Dupouy
  • Beaumont-sur-Oise, France, 95260
    • Centre Hospitalier Intercommunal des Portes de l'Oise
  • La roche sur yon, France, 85170
    • CHD Vendée
  • Lens, France, 62307
    • CH Docteur Schaffner
  • Montauban, France, 82013
    • CH de Montauban
  • Orleans, France, 45067
    • Centre Hospitalier Regional D'Orleans
  • Pointe-à-Pitre, France, 97159
    • CHU Pointe à Pitre les Abymes
  • Poissy, France, 78600
    • CHI Poissy Saint Germain
  • Pontoise, France, 95303
    • Centre Hospitalier Rene Dubos
  • Saint Nazaire, France, 44606
    • CH de Saint Nazaire
  • Saint-Denis (Réunion), France, 97405
    • CHU La Réunion, site de Saint Denis de la Réunion
  • Strasbourg, France, 67000
    • CHU de Strasbourg Nouvel Hôpital Civil
  • Tours, France, 37044
    • CHU Tours, site Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period with endotracheal tubes allowing SSD; During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage	Device: 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.
Active Comparator: Period with endotracheal tubes not allowing SSD; During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Collaborators: Ministry of Health, France; University Hospital, Tours

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2015
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Prevention; Surveillance; Ventilator-associated pneumonia; Critically ill patients; Subglottic-secretions
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents, Local; Anti-Infective Agents; Silver Sulfadiazine
• Other Study ID Numbers: CHD 052-15