Clinical trial NCT01948635: Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
Official title: Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Mechanical Ventilation Complication
Ventilator Associated Pneumonia
Keywords: tracheal cuff shape
microaspiration
pepsin
ventilator-associated pneumonia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Detailed description: Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak.

Recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.

Eligibility criteria: Inclusion Criteria:

* age \> or = 18 years
* tracheal intubation
* predictable duration of mechanical ventilation \> 48h
* enteral nutrition

Exclusion Criteria:

* pregnant women
* refuse to participate to the study
* no informed consent
* contre indication for semirecumbent position

Primary outcomes:
measure: Microaspiration of gastric contents
timeFrame: 48 hours after randomization
Secondary outcomes:
measure: Microaspiration of oropharyngeal secretions
timeFrame: 48 h after randomization
measure: Tracheobronchial colonization
timeFrame: 28 days after randomization
measure: Ventilator-associated pneumonia
timeFrame: 28 days after randomization
Other outcomes:
Locations:
city: Lille
country: France
facility: ICU, Salengro Hospital, University Hospital of Lille
state: Nord
city: Boulogne sur mer
country: France
facility: centre Hospitalier
city: Dunkerque
country: France
facility: Centre Hospitalier
city: Lens
country: France
facility: Centre Hospitalier
city: Lomme
country: France
facility: Centre Hospitalier St Philibert
city: Roubaix
country: France
facility: Centre hospitalier
city: Rouen
country: France
facility: Centre Hospitalier Universitaire
city: Tourcoing
country: France
facility: Centre Hospitalie
city: Valenciennes
country: France
facility: Centre Hospitalier
Study officials:
affiliation: CHRU de Lille
name: Saad Nseir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z.
citation: Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoReal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16.