Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy - Full Text View

Sponsored by:	University of Padova
Information provided by:	University of Padova
ClinicalTrials.gov Identifier:	NCT00771784

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.

MedlinePlus related topics: Neurologic Diseases

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771784

Contacts

Contact: Michele Carron, MD	+39 049 821 3090	michele.carron@unipd.it
Contact: Ulderico Freo, MD	+39 049 821 3094	ulderico.freo@unipd.it

Locations

Italy, PD
Intensive Care Unit, S. Anthony Hospital	Recruiting
Padova, PD, Italy, 35126
Contact: Michele Carron, MD +39 049 821 3090 michele.carron@unipd.it
Contact: Ulderico Freo, MD +39 049 821 3094 ulderico.freo@unipd.it
Sub-Investigator: Giuseppe Gagliardi, MD

Sponsors and Collaborators

University of Padova

Investigators

Study Chair:

Carlo Ori, Professor

Department of Pharmacology and Anesthesiology, University of Padova

More Information

Additional Information:

Link of the Anesthesia and Critical Care Section This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by University of Padova:

Endotracheal intubation
tracheostomy
laryngeal mask

Study placed in the following topic categories:

Sepsis
Respiratory Insufficiency
Heart Diseases
Respiratory Tract Diseases

Dilatation, Pathologic
Respiration Disorders
Wounds and Injuries

Additional relevant MeSH terms:

Respiratory Insufficiency
Heart Diseases
Respiratory Tract Diseases

Respiration Disorders
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009