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

NCT02585180 | Completed DMC

• 1 other identifier: CHD 052-15
• Study Type: interventional
• Target: 420
• Locations: 2 countries
• Sites: 15

Brief 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

Conditions

Ventilator-associated Pneumonia

Keywords

Ventilator-associated pneumonia; Surveillance; Subglottic-secretions; Critically ill patients; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.

  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

  Until weaning of mechanical ventilation, an expected average of 10 days

• Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance

  Until weaning of mechanical ventilation, an expected average of 10 days

• Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance

  Until weaning of mechanical ventilation, an expected average of 10 days

Study Arms (2)

Period with endotracheal tubes not allowing SSD

ACTIVE COMPARATOR

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

Period with endotracheal tubes allowing SSD

EXPERIMENTAL

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

Interventions

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

Period with endotracheal tubes not allowing SSD

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.

Period with endotracheal tubes allowing SSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient with no comprehension of the French language

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead
• Ministry of Health, France: collaborator
• University Hospital, Tours: collaborator

Study Sites (15)

CHU André Vésale

Montigny-le-Tilleul, 6110, Belgium

Location

CH Annecy Genevois

Annecy, 74374, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95100, France

Location

Centre Hospitalier Intercommunal des Portes de l'Oise

Beaumont-sur-Oise, 95260, France

Location

Chd Vendee

La Roche-sur-Yon, 85170, France

Location

CH Docteur Schaffner

Lens, 62307, France

Location

CH de Montauban

Montauban, 82013, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, 45067, France

Location

CHU Pointe à Pitre les Abymes

Pointe à Pitre, 97159, France

Location

CHI Poissy Saint Germain

Poissy, 78600, France

Location

Centre Hospitalier René Dubos

Pontoise, 95303, France

Location

CHU La Réunion, site de Saint Denis de la Réunion

Saint-Denis (Réunion), 97405, France

Location

CH de Saint Nazaire

Saint-Nazaire, 44606, France

Location

CHU de Strasbourg Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

CHU Tours, site Bretonneau

Tours, 37044, France

Location

Related 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.

  PMID: 23188467 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Claude LACHERADE, MD

  CHD VENDEE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 23, 2015
• Study Start: November 4, 2015
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

BE (1); FR (14)