CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 620 enrolled
Drug / intervention
Experimental 1 +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01114022
NCT01114022N/ACompleted

Comparison of Prevention Bacterial Inhalation of Patients on Mechanical Ventilation by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane

Assistance Publique - Hôpitaux de Paris·interventional·Posted Apr 30, 2010·Updated Aug 26, 2014

In Brief

A clinical study evaluating Experimental 1, Experimental, and 2 other interventions for Acute Respiratory Failure and Mechanical Ventilation Complication. Completed, enrolled 620 participants across 1 site.

Detailed Summary

A number of techniques have been recommended for the prevention of ventilator acquired pneumonia (VAP). These techniques - such as patient positioning, continuous sub-glottic suction of the secretions, selective decontamination of the digestive tract etc… - aim at prevent the inhalation of oro-pharyngeal contaminated secretions around the cuff of the tracheal tube used for connecting the patient to the machine. Their efficacy has been regularly challenged and they are still unable to suppress totally the occurrence of VAP. The cuff of the tracheal tube used for long-term MV in the ICU is most often a low pressure high volume polyvinyl chloride (PVC) cuff in order to adhere to a large surface of the tracheal wall without inducing ischemic lesions. Recent advances allowed industrial companies to provide us with 1) polyurethane cuffs and 2) cuffs with a conic shape, both potentially offering a better tightness against inhalation at least in VITRO and in animal models. The effect on the reduction of VAP incidence has been suggested by several pilot series. The aim of the present project is to assess the efficacy of four types of cuffs (PVC with a conic or a cylinder shape and polyurethane with a conic or a cylinder shape) to prevent tracheal colonisation. We shall measure both oro-pharyngeal and tracheal colonisation during the hours and days following intubation. This will be done in 600 ICU patients of four university affiliated centres from France and Tunisia divided in 64 cluster randomized groups. The results of this research will confirm (or not) the rationale to perform a larger study designed specifically to address the impact on VAP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 30, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.2 years ago

Interventions

Experimental 1device

oeso pharyngeal device

Experimentaldevice

oeso pharyngeal device

experimental 3device

oeso pharyngeal device

Active comparatordevice

oeso pharyngeal device