Clinical Trials Directory

Trials / Unknown

UnknownNCT01691222

Tracheostomy in ICU With a Double Lumen Endotracheal Tube

Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
University of Genova · Academic / Other
Sex
All
Age
18 Years – 82 Years
Healthy volunteers
Not accepted

Summary

Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. This situation may lead to many disadvantages for ventilation and airway protection of critically ill patients during the procedures. The use of double lumen endotracheal tube dedicated to the percutaneous tracheostomies may: 1. improve the ventilation of patients during the procedure, 2. protect the posterior tracheal wall from damage related to the different step of tracheostomies, 3. protect the lungs from blood and secretions coming down from the chosen site of tracheostomy. So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen endotracheal tube.

Conditions

Interventions

TypeNameDescription
DEVICEDouble lumen endotracheal tube tracheostomyPercutaneous tracheostomy in this study will be performed with the use of a dedicated double-lumen endotracheal tube. The dedicated double-lumen endotracheal tube (Deas S.R.L, Italy) has an upper and a lower lumen. The upper one will be occupied by flexible fiberoptic bronchoscope while the lower one is exclusively dedicated to patient ventilation during the procedure. The lower lumen has a a semi-elliptical cross section. This tube will be placed in the patient airway with a direct laryngoscopy. After this intubation, a percutaneous dilatational tracheostomy will be performed with the standard techniques recognised in the literature.

Timeline

Start date
2012-07-01
Primary completion
2014-12-01
Completion
2015-06-01
First posted
2012-09-24
Last updated
2013-07-03

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT01691222. Inclusion in this directory is not an endorsement.