Acute Respiratory Failure, Heart Failure, Neurological Disease
Conditions
Keywords
Bedside percutaneous tracheostomy, Intensive Care Unit, Dedicated Double-lumen tube, Ineffective Airway Clearance, weaning failure
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: 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.
Interventions
DEVICEDouble 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
University of Genova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in gas-exchange | at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes) | The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in peak airway pressure | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | the investigator will record peak airway pressure |
| change in plateau airway pressure | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | the investigator will record plateau airway pressure |
| change in arterial carbon dioxide | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | the investigator will perform an arterial blood gas to evaluate PaCO2 |
| early complications | in the first 24 hours from the end of the procedure | 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, |
| late complications | from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks) | late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma. |
| change in air-trapping | at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) | the investigator will record auto-PEEP at the of expiration as a measure of air-trapping |
Countries
Italy
Contacts
Primary ContactPaolo Pelosi, Professor
Outcome results
None listed