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

NCT ID: NCT00771784

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Keywords

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Endotracheal intubation tracheostomy laryngeal mask

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Short term endotracheal intubation.

No interventions assigned to this group

2

Long term endotracheal intubation.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Department of Pharmacology and Anesthesiology, University of Padova

Principal Investigators

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Carlo Ori, Professor

Role: STUDY_CHAIR

Department of Pharmacology and Anesthesiology, University of Padova

Locations

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Intensive Care Unit, S. Anthony Hospital

Padua, PD, Italy

Site Status

Countries

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Italy

Related Links

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http://www.istar.unipd.it/

Link of the Anesthesia and Critical Care Section

Other Identifiers

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68144

Identifier Type: -

Identifier Source: org_study_id