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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double lumen endotracheal tube tracheostomy | Other | Tracheostomy with a dedicated double lumen endotracheal tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double lumen endotracheal tube tracheostomy | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Pelosi, Professor | Contact | +39 010 555 3136 | ppelosi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Pelosi, Professor | Universita degli Studi di Genova | Study Director |
| Giuseppe Servillo, Professor | Federico II University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Genoa | Recruiting | Genoa | Italy | 16132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16342657 | Background | Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8. doi: 10.4065/80.12.1632. | |
| 17588767 | Background | De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
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) |
| University of Naples "Federico II" | Recruiting | Naples | Italy | 80100 | Italy |
|
| 18440435 | Background | King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002. |
| 20667153 | Background | Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68. |
| 20523214 | Background | Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0. |
| 3996056 | Background | Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715. |
| 9142576 | Background | Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92. doi: 10.1007/s001340050345. |
| 2343371 | Background | Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5. |
| 10334157 | Background | Trottier SJ, Hazard PB, Sakabu SA, Levine JH, Troop BR, Thompson JA, McNary R. Posterior tracheal wall perforation during percutaneous dilational tracheostomy: an investigation into its mechanism and prevention. Chest. 1999 May;115(5):1383-9. doi: 10.1378/chest.115.5.1383. |
| 19295287 | Background | Campos JH. Update on tracheobronchial anatomy and flexible fiberoptic bronchoscopy in thoracic anesthesia. Curr Opin Anaesthesiol. 2009 Feb;22(1):4-10. doi: 10.1097/ACO.0b013e32831a43ab. |
| 25375865 | Derived | Vargas M, Pelosi P, Tessitore G, Aloj F, Brunetti I, Arditi E, Salami D, Kacmarek RM, Servillo G. Percutaneous dilatational tracheostomy with a double-lumen endotracheal tube: a comparison of feasibility, gas exchange, and airway pressures. Chest. 2015 May;147(5):1267-1274. doi: 10.1378/chest.14-1465. |