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
  Purpose

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


Condition
Neurological Diseases, Heart or Respiratory Failure,
Sepsis, Trauma.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Short- and of Long-term Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy.

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • Ventilatory parameters during percutaneous tracheostomy [ Time Frame: Thirty minutes. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Scoring of laryngeal lesions, blood gas exchange, morbidity, mortality. [ Time Frame: Thirty minutes. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Short term endotracheal intubation.
2
Long term endotracheal intubation.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ICU patients.

Criteria

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
  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: NCT00771784

Locations
Italy
Intensive Care Unit, S. Anthony Hospital
Padova, PD, Italy, 35126
Sponsors and Collaborators
University of Padova
Investigators
Study Chair: Carlo Ori, Professor Department of Pharmacology and Anesthesiology, University of Padova
  More Information

Additional Information:
No publications provided

Responsible Party: Michele Carron/MD, Department of Pharmacology and Anesthesiology, University of Padova
ClinicalTrials.gov Identifier: NCT00771784     History of Changes
Other Study ID Numbers: 68144
Study First Received: October 10, 2008
Last Updated: August 21, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Padova:
Endotracheal intubation
tracheostomy
laryngeal mask

Additional relevant MeSH terms:
Heart Diseases
Nervous System Diseases
Sepsis
Respiratory Insufficiency
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014