NCT02583308

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
896

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

November 4, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

October 20, 2015

Last Update Submit

March 19, 2021

Conditions

Ventilator-associated Pneumonia

Keywords

Ventilator-associated pneumoniaSurveillanceSubglottic-secretionsCritically ill patientsPrevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

  • Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.

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

  • 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

  • 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

  • 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

  • +10 more secondary outcomes

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

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 SSDDEVICE

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 SSDDEVICE

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 (SSD) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, 85000, 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)

  • 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.

    PMID: 14647884BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological 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 22, 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)