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Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy

This study has been completed.
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00771784
First received: October 10, 2008
Last updated: August 21, 2012
Last verified: August 2012
History of Changes

October 10, 2008
August 21, 2012
July 2008
July 2010   (final data collection date for primary outcome measure)
Ventilatory parameters during percutaneous tracheostomy [ Time Frame: Thirty minutes. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00771784 on ClinicalTrials.gov Archive Site
Scoring of laryngeal lesions, blood gas exchange, morbidity, mortality. [ Time Frame: Thirty minutes. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy
Effects of Short- and of Long-term Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy.

The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask during percutaneous tracheostomy.

Percutaneous tracheostomy is routinely performed while patients are being ventilated with a laryngeal mask. The efficacy of ventilation during tracheostomy may be affected by length of previous endotracheal intubation.

This is an observational and monocentric study aimed to evaluate the impact of length of endotracheal intubation on efficacy of lung ventilation with a laryngeal mask. Two groups of patients who have to undergo elective percutaneous tracheostomy after either a short or long endotracheal intubation will be enrolled.

Data on the correlational effects of the endotracheal tube on the integrity of laryngeal structures and on ventilation will be collected.

Statistical analyses will use standard tests to compare the two groups of patients.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

ICU patients.
  • Neurological Diseases, Heart or Respiratory Failure,
  • Sepsis, Trauma.
Not Provided
  • 1
    Short term endotracheal intubation.
  • 2
    Long term endotracheal intubation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18-80 years
  • mechanical ventilation
  • need of percutaneous tracheostomy

Exclusion Criteria:

  • previous pathologies of upper airways or of oesophagus
  • risk of bleeding
  • need of FiO2 >70% and/or of PEEP >10 cm H2O
  • difficult insertion of laryngeal mask
  • impossibility of endoscopic visualization of the laryngeal structures
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00771784
68144
Yes
Michele Carron/MD, Department of Pharmacology and Anesthesiology, University of Padova
University of Padova
Not Provided
Study Chair: Carlo Ori, Professor Department of Pharmacology and Anesthesiology, University of Padova
University of Padova
August 2012

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