Tracheostomy in ICU With a Double Lumen Endotracheal Tube
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01691222|
Recruitment Status : Unknown
Verified July 2013 by Paolo Pelosi, University of Genova.
Recruitment status was: Recruiting
First Posted : September 24, 2012
Last Update Posted : July 3, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure Heart Failure Neurological Disease||Device: Double lumen endotracheal tube tracheostomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||June 2015|
Double lumen endotracheal tube tracheostomy
Tracheostomy with a dedicated double lumen endotracheal tube
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.
Other Name: International Patent n° PCT/IT2012/000154
- change in gas-exchange [ Time Frame: 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
- change in arterial carbon dioxide [ Time Frame: 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
- change in peak airway pressure [ Time Frame: 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 [ Time Frame: 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 air-trapping [ Time Frame: 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
- early complications [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691222
|Contact: Paolo Pelosi, Professor||+39 010 555 firstname.lastname@example.org|
|University of Genoa||Recruiting|
|Genoa, Italy, 16132|
|Contact: Paolo Pelosi, Professor + 39 0101 5553136 email@example.com|
|Principal Investigator: Paolo Pelosi, Professor|
|Sub-Investigator: Maria Vargas, MD|
|University of Naples "Federico II"||Recruiting|
|Naples, Italy, 80100|
|Contact: Giuseppe Servillo, Professor +39 081 7463552 firstname.lastname@example.org|
|Principal Investigator: Giuseppe Servillo, Professor|
|Study Director:||Paolo Pelosi, Professor||University of Genoa|
|Study Director:||Giuseppe Servillo, Professor||Federico II University|