Tracheostomy in ICU With a Double Lumen Endotracheal Tube

This study is currently recruiting participants.
Verified July 2013 by University of Genova
Sponsor:
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova
ClinicalTrials.gov Identifier:
NCT01691222
First received: August 30, 2012
Last updated: July 2, 2013
Last verified: July 2013

August 30, 2012
July 2, 2013
July 2012
December 2014   (final data collection date for primary outcome measure)
change in gas-exchange [ Time Frame: at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes) ] [ Designated as safety issue: Yes ]
The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio
Same as current
Complete list of historical versions of study NCT01691222 on ClinicalTrials.gov Archive Site
  • change in arterial carbon dioxide [ Time Frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) ] [ Designated as safety issue: Yes ]
    the investigator will perform an arterial blood gas to evaluate PaCO2
  • change in peak airway pressure [ Time Frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) ] [ Designated as safety issue: Yes ]
    the investigator will record peak airway pressure
  • change in plateau airway pressure [ Time Frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) ] [ Designated as safety issue: Yes ]
    the investigator will record plateau airway pressure
  • change in air-trapping [ Time Frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes) ] [ Designated as safety issue: Yes ]
    the investigator will record auto-PEEP at the of expiration as a measure of air-trapping
  • early complications [ Time Frame: in the first 24 hours from the end of the procedure ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks) ] [ Designated as safety issue: Yes ]
    late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
Same as current
Not Provided
Not Provided
 
Tracheostomy in ICU With a Double Lumen Endotracheal Tube
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Acute Respiratory Failure
  • Heart Failure
  • Neurological Disease
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 Name: International Patent n° PCT/IT2012/000154
Double lumen endotracheal tube tracheostomy
Tracheostomy with a dedicated double lumen endotracheal tube
Intervention: Device: Double lumen endotracheal tube tracheostomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 82 Years
No
Contact: Paolo Pelosi, Professor +39 010 555 3136 ppelosi@hotmail.com
Italy
 
NCT01691222
90/12
Yes
Paolo Pelosi, University of Genova
University of Genova
Not Provided
Study Director: Paolo Pelosi, Professor University of Genoa
Study Director: Giuseppe Servillo, Professor Federico II University
University of Genova
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP