Tracheostomy in ICU With a Double Lumen Endotracheal Tube

NCT01691222 | Unknown DMC

• 1 other identifier: 90/12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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:

1. 1.improve the ventilation of patients during the procedure,
2. 2.protect the posterior tracheal wall from damage related to the different step of tracheostomies,
3. 3.protect the lungs from blood and secretions coming down from the chosen site of tracheostomy.

Conditions

Acute Respiratory Failure; Heart Failure; Neurological Disease

Keywords

Bedside percutaneous tracheostomy; Intensive Care Unit; Dedicated Double-lumen tube; Ineffective Airway Clearance; weaning failure

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• change in arterial carbon dioxide

  at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)

• change in 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

  at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)

• change in air-trapping

  at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)

• early complications

  in the first 24 hours from the end of the procedure

Study Arms (1)

Double lumen endotracheal tube tracheostomy

OTHER

Tracheostomy with a dedicated double lumen endotracheal tube

Device: Double lumen endotracheal tube tracheostomy

Interventions

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.

Also known as: International Patent n° PCT/IT2012/000154

Double lumen endotracheal tube tracheostomy

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years and at least one of following criteria:
• prolonged endotracheal intubation
• prolonged mechanical ventilation
• difficult/prolonged weaning
• inability to protect the airway

You may not qualify if:

• infection of neck tissues
• previous surgical neck interventions
• recent surgical interventions or fracture of the cervical spine

Sponsors & Collaborators

• University of Genova: lead

Study Sites (2)

University of Genoa

Genoa, Italy, 16132, Italy

RECRUITING

University of Naples "Federico II"

Naples, Italy, 80100, Italy

RECRUITING

Related Publications (11)

• 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.

  PMID: 16342657 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.

  PMID: 17588767 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.

  PMID: 18440435 BACKGROUND

• Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.

  PMID: 20667153 BACKGROUND

• Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0.

  PMID: 20523214 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.

  PMID: 3996056 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.

  PMID: 9142576 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.

  PMID: 2343371 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.

  PMID: 10334157 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.

  PMID: 19295287 BACKGROUND

• 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.

  PMID: 25375865 DERIVED

MeSH Terms

Conditions

Heart Failure; Nervous System Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Paolo Pelosi, Professor

  Universita degli Studi di Genova

  STUDY DIRECTOR

• Giuseppe Servillo, Professor

  Federico II University

  STUDY DIRECTOR

Central Study Contacts

Paolo Pelosi, Professor

CONTACT

+39 010 555 3136; ppelosi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor chair of Anesthesiology and Intensive Care Medicine. Chief of Intensive Care Unit

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 24, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

IT (2)