MedTrace Logo

Tracheostomy in ICU With a Double Lumen Endotracheal Tube

NCT01691222 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-07-03

No results posted yet for this study

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

DEVICE

Double lumen endotracheal tube tracheostomy

Percutaneous 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.

Sponsors & Collaborators

  • University of Genova

    lead OTHER

Principal Investigators

  • Paolo Pelosi, Professor · Universita degli Studi di Genova

  • Giuseppe Servillo, Professor · Federico II University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691222 on ClinicalTrials.gov