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.

NCT02534974 | Completed

• 1 other identifier: AGATE
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Ventilation-associated Pneumonia; Severe Trauma Patient

Keywords

Critical care; Trauma patients

Outcome Measures

Primary Outcomes (1)

• Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition

  28 days

Secondary Outcomes (9)

• Proportion of patients having developed VAP in ICU according to the ATS definition

  max 60 days

• Proportion of patients having developed early (≤ day 7) or late (> day 7) VAP in ICU according to the ATS definition

  max 60 days

• Time to first episode of VAP diagnosis according to the ATS definition

  max 60 days

• Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition

  max 60 days

• Number of ventilator free days

  max 60 days

Interventions

NOSTEN DEVICE

Also known as: device providing continuous pneumatic regulation of tube cuff pressure

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (13)

Sigismond LASOCKI

Angers, 49100, France

Location

Sébastien PILI FLOURY

Besançon, 25030, France

Location

Jean Michel CONSTANTIN

Clermont-Ferrand, 63100, France

Location

Catherine PAUGAM

Clichy, 92110, France

Location

Belaid BOUHEMAD

Dijon, 21000, France

Location

Dominique FALCON

Grenoble, 38700, France

Location

Marc LEONE

Marseille, 13915, France

Location

Karim ASEHNOUNE

Nantes, 44000, France

Location

Carole ICHAI

Nice, 06000, France

Location

Jean Yves LEFRANT

Nîmes, 30900, France

Location

Olivier MIMOZ

Poitiers, 86021, France

Location

Benoit VEBER

Rouen, 76031, France

Location

Julien POTTECHER

Strasbourg, 67098, France

Location

Related Publications (2)

• Marjanovic N, Boisson M, Asehnoune K, Foucrier A, Lasocki S, Ichai C, Leone M, Pottecher J, Lefrant JY, Falcon D, Veber B, Chabanne R, Drevet CM, Pili-Floury S, Dahyot-Fizelier C, Kerforne T, Seguin S, de Keizer J, Frasca D, Guenezan J, Mimoz O; AGATE Study Group. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study. Chest. 2021 Aug;160(2):499-508. doi: 10.1016/j.chest.2021.03.007. Epub 2021 Mar 13.

  PMID: 33727034 DERIVED

• Marjanovic N, Frasca D, Asehnoune K, Paugam C, Lasocki S, Ichai C, Lefrant JY, Leone M, Dahyot-Fizelier C, Pottecher J, Falcon D, Veber B, Constantin JM, Seguin S, Guenezan J, Mimoz O; AGATE study group. Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol. BMJ Open. 2017 Aug 7;7(8):e017003. doi: 10.1136/bmjopen-2017-017003.

  PMID: 28790042 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 28, 2015
• Study Start: July 31, 2015
• Primary Completion: February 15, 2018
• Study Completion: April 11, 2018
• Last Updated: April 25, 2019

Record last verified: 2018-04

Locations

FR (13)