Tracheostomy in ICU With a Double Lumen Endotracheal Tube

Heart Failure Clinical Trial

Official title:

Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01691222
• Other study ID #: 90/12
• Status: Recruiting
• Phase: N/A
• First received: August 30, 2012
• Last updated: July 2, 2013
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2013
• Source: University of Genova
• Contact: Paolo Pelosi, Professor
• Phone: +39 010 555 3136
• Email: ppelosi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Heart Failure
• Nervous System Diseases
• Neurological Disease
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Genoa	Genoa
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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

Outcome

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