Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia; Critical Illness; Mechanical Ventilation Complication
• Interventions: Device: tapered PVC-cuffed tracheal tubes; Device: Standard PVC-cuffed tracheal tube

• Registration Number: NCT01948635
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study First Submitted: 2013-08-31
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Study Start: 2014-04
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tapered PVC-cuffed tracheal tubes	tapered PVC-cuffed tracheal tubes	Patients in this arm will be intubated with tapered PVC-tracheal tubes
Standard PVC-cuffed tracheal tube	Standard PVC-cuffed tracheal tube	Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes

Primary Outcome Measures

Name	Time	Method
Microaspiration of gastric contents	48 hours after randomization	Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents

Secondary Outcome Measures

Name	Time	Method
Microaspiration of oropharyngeal secretions	48 h after randomization	amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions
Tracheobronchial colonization	28 days after randomization
Ventilator-associated pneumonia	28 days after randomization

Trial Locations

Locations (7)

Centre Hospitalie; 🇫🇷 Tourcoing, France

centre Hospitalier; 🇫🇷 Boulogne sur mer, France

Centre Hospitalier; 🇫🇷 Valenciennes, France

Centre Hospitalier St Philibert; 🇫🇷 Lomme, France

Centre Hospitalier Universitaire; 🇫🇷 Rouen, France

ICU, Salengro Hospital, University Hospital of Lille; 🇫🇷 Lille, Nord, France

Centre hospitalier; 🇫🇷 Roubaix, France