Tracheostomy in ICU With a Double Lumen Endotracheal Tube

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Acute Respiratory Failure
Heart Failure
Neurological Disease
Device: Double lumen endotracheal tube tracheostomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube

Resource links provided by NLM:


Further study details as provided by University of Genova:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Double lumen endotracheal tube tracheostomy
Tracheostomy with a dedicated double lumen endotracheal tube
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

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691222

Contacts
Contact: Paolo Pelosi, Professor +39 010 555 3136 ppelosi@hotmail.com

Locations
Italy
University of Genoa Recruiting
Genoa, Italy, 16132
Contact: Paolo Pelosi, Professor    + 39 0101 5553136    ppelosi@hotmail.com   
Principal Investigator: Paolo Pelosi, Professor         
Sub-Investigator: Maria Vargas, MD         
University of Naples "Federico II" Recruiting
Naples, Italy, 80100
Contact: Giuseppe Servillo, Professor    +39 081 7463552    servillo@unina.it   
Principal Investigator: Giuseppe Servillo, Professor         
Sponsors and Collaborators
University of Genova
Investigators
Study Director: Paolo Pelosi, Professor University of Genoa
Study Director: Giuseppe Servillo, Professor Federico II University
  More Information

Publications:

Responsible Party: Paolo Pelosi, Full Professor chair of Anesthesiology and Intensive Care Medicine. Chief of Intensive Care Unit, University of Genova
ClinicalTrials.gov Identifier: NCT01691222     History of Changes
Other Study ID Numbers: 90/12
Study First Received: August 30, 2012
Last Updated: July 2, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Genova:
Bedside percutaneous tracheostomy
Intensive Care Unit
Dedicated Double-lumen tube
Ineffective Airway Clearance
weaning failure

Additional relevant MeSH terms:
Heart Failure
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on October 01, 2014