Heart Failure Clinical Trial
Official title:
Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 82 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Italy | University of Genoa | Genoa | |
Italy | University of Naples "Federico II" | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Genova |
Italy,
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. — View Citation
Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. — View Citation
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. — View Citation
Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68. Review. — View Citation
Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92. — View Citation
Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5. — View Citation
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. — View Citation
Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Yes |
Secondary | 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) | Yes |
Secondary | 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) | Yes |
Secondary | 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) | Yes |
Secondary | 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) | Yes |
Secondary | 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 | Yes |
Secondary | 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) | Yes |
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