NCT02515617

Brief Summary

In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,577

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
4 countries

25 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

July 31, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 5, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

July 31, 2015

Last Update Submit

January 14, 2019

Conditions

Ventilator-associated Pneumonia

Keywords

Ventilator-associated pneumoniaSubglottic-secretions drainageCritically ill patientsCost-utility analysisPrevention

Outcome Measures

Primary Outcomes (1)

  • Incremental cost-utility ratio

    Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation

    1 year after ICU admission

Secondary Outcomes (19)

  • Incremental cost-effectiveness ratio

    1 year after ICU admission

  • Incremental cost-utility ratio (subgroup analysis)

    1 year after ICU admission

  • Incremental cost-effectiveness ratio

    1 year after ICU admission

  • Budget impact analysis

    5 years

  • Microbiologically-confirmed VAP incidence

    90 days after the start of invasive mechanical ventilation

  • +14 more secondary outcomes

Study Arms (2)

Period with endotracheal tubes not allowing SSD

ACTIVE COMPARATOR

During this period, 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, 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 ICU 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 (25)

CHU André Vésale ,

Montigny-le-Tilleul, 6110, Belgium

Location

CH Angoulème

Angoulème, 16959, France

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

CHU Dijon

Dijon, 21000, France

Location

CHD Vendee

La Roche-sur-Yon, 85000, France

Location

CH Docteur Schaffner

Lens, 62307, France

Location

Centre Hospitalier François Quesnay

Mantes-la-Jolie, 78200, France

Location

CHU marseilles, Hôpital Nord

Marseilels, 13000, France

Location

CH de Montauban

Montauban, 82013, France

Location

CHU Nantes

Nantes, 44000, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, 45067, France

Location

CHI Poissy Saint Germain

Poissy, 78600, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier René Dubos

Pontoise, 95303, France

Location

Hôpital Delafontaine

Saint-Denis, 93200, France

Location

CH de Saint Nazaire

Saint-Nazaire, 44606, France

Location

CHU de Strasbourg Hôpital de Hautepierre

Strasbourg, 67000, France

Location

CHU de Strasbourg Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

CHU Tours, site Bretonneau

Tours, 37044, France

Location

CHU Tours, site Trousseau

Tours, France

Location

CHU Pointe à Pitre les Abymes

Pointe-à-Pitre, 97159, Guadeloupe

Location

CHU La Réunion, site de Saint Denis de la Réunion

Saint-Denis, 97405, Reunion

Location

CHU La Réunion, site de Saint Pierre de la Réunion

Saint-Pierre, 97448, Reunion

Location

Related Publications (5)

  • Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9.

    PMID: 21478738BACKGROUND

  • Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.

    PMID: 20522796BACKGROUND

  • Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available.

    PMID: 25376073BACKGROUND

  • Branch-Elliman W, Wright SB, Howell MD. Determining the Ideal Strategy for Ventilator-associated Pneumonia Prevention. Cost-Benefit Analysis. Am J Respir Crit Care Med. 2015 Jul 1;192(1):57-63. doi: 10.1164/rccm.201412-2316OC.

    PMID: 25871807BACKGROUND

  • Loupec T, Petitpas F, Kalfon P, Mimoz O. Subglottic secretion drainage in prevention of ventilator-associated pneumonia: mind the gap between studies and reality. Crit Care. 2013 Dec 9;17(6):R286. doi: 10.1186/cc13149. No abstract available.

    PMID: 24321315BACKGROUND

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 5, 2015

Study Start

November 5, 2015

Primary Completion

November 22, 2018

Study Completion

November 22, 2018

Last Updated

January 15, 2019

Record last verified: 2018-01

Locations

FR(21)GU(1)BE(1)RE(2)