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

NCT ID: NCT02585180

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-04
• Study Completion Date: 2017-11-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Endotracheal tubes not allowing SSD

Intervention Type: 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 allowing SSD

During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Group Type: EXPERIMENTAL

Endotracheal tubes allowing SSD

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Tours

OTHER

Sponsor Role: collaborator

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Claude LACHERADE, MD

Role: PRINCIPAL_INVESTIGATOR

CHD VENDEE

Locations

CHU André Vésale

Montigny-le-Tilleul, , Belgium

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

Orléans, , France

CHU Pointe à Pitre les Abymes

Pointe à Pitre, , France

CHI Poissy Saint Germain

Poissy, , France

Centre Hospitalier René Dubos

Pontoise, , France

CHU La Réunion, site de Saint Denis de la Réunion

Saint-Denis (Réunion), , France

CH de Saint Nazaire

Saint-Nazaire, , France

CHU de Strasbourg Nouvel Hôpital Civil

Strasbourg, , France

CHU Tours, site Bretonneau

Tours, , France

Countries

Belgium; France

References

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.

Reference Type: BACKGROUND

PMID: 23188467 (View on PubMed)

Other Identifiers

CHD 052-15

Identifier Type: -

Identifier Source: org_study_id