Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

Critical Illness Clinical Trial

— BestCuff  

Official title:

Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948635
• Other study ID #: 2012_45
• Secondary ID: 2013 A00534 41PH
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation Complication
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Device:
• tapered PVC-cuffed tracheal tubes
Patients will be intubated with tapered-shape tracheal tubes
• Standard PVC-cuffed tracheal tube
Patients will be intubated with standard PVC cuffed tracheal tubes

Locations

Country	Name	City	State
France	centre Hospitalier	Boulogne sur mer
France	Centre Hospitalier	Dunkerque
France	Centre Hospitalier	Lens
France	ICU, Salengro Hospital, University Hospital of Lille	Lille	Nord
France	Centre Hospitalier St Philibert	Lomme
France	Centre hospitalier	Roubaix
France	Centre Hospitalier Universitaire	Rouen
France	Centre Hospitalie	Tourcoing
France	Centre Hospitalier	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microaspiration of gastric contents	Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents	48 hours after randomization
Secondary	Microaspiration of oropharyngeal secretions	amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions	48 h after randomization
Secondary	Tracheobronchial colonization		28 days after randomization
Secondary	Ventilator-associated pneumonia		28 days after randomization