Tracheostomy in ICU With a Double Lumen Endotracheal Tube
Study Details
Study Description
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:
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improve the ventilation of patients during the procedure,
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protect the posterior tracheal wall from damage related to the different step of tracheostomies,
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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 |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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 Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥ 18 years and at least one of following criteria:
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prolonged endotracheal intubation
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prolonged mechanical ventilation
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difficult/prolonged weaning
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inability to protect the airway
Exclusion Criteria:
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infection of neck tissues
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previous surgical neck interventions
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recent surgical interventions or fracture of the cervical spine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Genoa | Genoa | Italy | 16132 | |
| 2 | University of Naples "Federico II" | Naples | Italy | 80100 |
Sponsors and Collaborators
- University of Genova
Investigators
- Study Director: Paolo Pelosi, Professor, University of Genoa
- Study Director: Giuseppe Servillo, Professor, Federico II University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9.
- 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. Epub 2007 Jun 27. Review.
- Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68. Review.
- Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92.
- Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5.
- 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. Review.
- Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0. Review.
- Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8. Review.
- 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.
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