Impact of the Addition of a Device Providing Continuous Pneumatic Regulation of Tube Cuff Pressure to an Overall Strategy Aimed at Preventing Ventilator-associated Pneumonia in the Severe Trauma Patient. A Multicentre, Randomised, Controlled Study.

Ventilation-associated Pneumonia Clinical Trial

— AGATE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534974
• Other study ID #: AGATE
• Status: Completed
• Phase: N/A
• Start date: July 31, 2015
• Est. completion date: April 11, 2018

Study information

• Verified date: April 2018
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. As was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of nosocomial infections contracted in intensive care, success in this preventive endeavour depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation.

Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in maintaining tracheal balloon pressure than intermittent adjustments using a hand-held manometer. In one study, these devices clearly facilitated diminution of microaspiration of gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22 VAP/1000 days of mechanical ventilation; p = 0.005).

The investigators are putting forward the hypothesis that by adjoining a device providing continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°, oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP incidence by 50% in severely traumatised patients whose condition necessitates mechanical ventilation of an expected duration exceeding 48h.

Ours is the first large-scale study to evaluate the interest of an innovative technology bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care populations the most at risk, namely severe trauma patients, a population presently benefiting from the other recommended preventive measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: April 11, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients having a severe trauma as defined by an Injury Severity Score (ISS) >15,

• Aged at least 18 years,

• Intubated for less than 15h,

• Necessitating recourse to mechanical ventilation for an expected period = 48h,

• Participating in a social security scheme or benefiting from such a scheme by means of a third party.

Exclusion Criteria:

• Patient likely to die over the 48h following admission,

• Nasotracheal intubation,

• Patient intubated through a tracheal tube with subglottic secretion drainage

• Intubation carried out 24h or more after the trauma,

• Ventilation with tracheotomy,

• Refusal to participate in the research,

• Contraindication to the head-up position,

• Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection,

• Persons benefiting from reinforced protection or persons deprived of freedom subsequent to a legal or administrative decision, minors under legal protection

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Severe Trauma Patient
• Ventilation-associated Pneumonia
• Wounds and Injuries

Intervention

Device:
• NOSTEN

Locations

Country	Name	City	State
France	Sigismond LASOCKI	Angers
France	Sébastien PILI FLOURY	Besançon
France	Jean Michel CONSTANTIN	Clermont-Ferrand
France	Catherine PAUGAM	Clichy
France	Belaid BOUHEMAD	Dijon
France	Dominique FALCON	Grenoble
France	Marc LEONE	Marseille
France	Karim ASEHNOUNE	Nantes
France	Carole ICHAI	Nice
France	Jean Yves LEFRANT	Nîmes
France	Olivier MIMOZ	Poitiers
France	Benoit VEBER	Rouen
France	Julien POTTECHER	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition		28 days
Secondary	Proportion of patients having developed VAP in ICU according to the ATS definition		max 60 days
Secondary	Proportion of patients having developed early (= day 7) or late (> day 7) VAP in ICU according to the ATS definition		max 60 days
Secondary	Time to first episode of VAP diagnosis according to the ATS definition		max 60 days
Secondary	Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition		max 60 days
Secondary	Number of ventilator free days		max 60 days
Secondary	Number of antibiotic free days		max 60 days
Secondary	ICU length-of-stay		max 60 days
Secondary	Proportion of patient who died during their ICU stay		max 60 days
Secondary	Proportion of patients requiring corticosteroids or bronchodilators within 48 hours of tracheal extubation		max 60 days