Clinical trial NCT01691222: Tracheostomy in ICU With a Double Lumen Endotracheal Tube
Official title: Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Heart Failure
Neurological Disease
Keywords: Bedside percutaneous tracheostomy
Intensive Care Unit
Dedicated Double-lumen tube
Ineffective Airway Clearance
weaning failure
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: change in gas-exchange
timeFrame: at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)
Secondary outcomes:
measure: change in arterial carbon dioxide
timeFrame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
measure: change in peak airway pressure
timeFrame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
measure: change in plateau airway pressure
timeFrame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
measure: change in air-trapping
timeFrame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
measure: early complications
timeFrame: in the first 24 hours from the end of the procedure
measure: late complications
timeFrame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: University of Genoa
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Universita degli Studi di Genova
name: Paolo Pelosi, Professor
role: STUDY_DIRECTOR
affiliation: Federico II University
name: Giuseppe Servillo, Professor
role: STUDY_DIRECTOR
References:
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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.
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. doi: 10.1378/chest.115.5.1383.
citation: 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.
citation: 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.