Tracheostomy in ICU With a Double Lumen Endotracheal Tube

Study Overview
=================
Brief 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: improve the ventilation of patients during the procedure, protect the posterior tracheal wall from damage related to the different step of tracheostomies, 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.

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

Conditions
-----------------
Acute Respiratory Failure, Heart Failure, Neurological Disease

Intervention / Treatment
-----------------
* Device: Double lumen endotracheal tube tracheostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years and at least one of following criteria: prolonged endotracheal intubation prolonged mechanical ventilation difficult/prolonged weaning inability to protect the airway Exclusion Criteria: infection of neck tissues previous surgical neck interventions recent surgical interventions or fracture of the cervical spine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Double lumen endotracheal tube tracheostomy<br>Tracheostomy with a dedicated double lumen endotracheal tube | Device: Double lumen endotracheal tube tracheostomy<br>* 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.<br>* Other names: International Patent n° PCT/IT2012/000154;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in gas-exchange | The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio | at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in arterial carbon dioxide | the investigator will perform an arterial blood gas to evaluate PaCO2 | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | 
| change in peak airway pressure | the investigator will record peak airway pressure | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | 
| change in plateau airway pressure | the investigator will record plateau airway pressure | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | 
| change in air-trapping | the investigator will record auto-PEEP at the of expiration as a measure of air-trapping | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | 
| early complications | early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax, | in the first 24 hours from the end of the procedure | 
| late complications | late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma. | from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bedside percutaneous tracheostomy, Intensive Care Unit, Dedicated Double-lumen tube, Ineffective Airway Clearance, weaning failure