CClinicalTrials.gg
CompletedNCT00771784Updated Aug 22, 2012

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

An observational study in Neurological Diseases, Heart or Respiratory Failure, and Sepsis, Trauma., sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-08-22.

Sponsored by University of Padova · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • Endotracheal intubation
  • tracheostomy
  • laryngeal mask
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

ICU patients.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)

Groups and cohorts

  • 1

    Short term endotracheal intubation.

  • 2

    Long term endotracheal intubation.

06

What researchers measure

Primary outcomes

  1. Ventilatory parameters during percutaneous tracheostomy

    Time frame: Thirty minutes.

Secondary outcomes

  1. Scoring of laryngeal lesions, blood gas exchange, morbidity, mortality.

    Time frame: Thirty minutes.

07

Study locations

1 site
  • Intensive Care Unit, S. Anthony Hospital
    Padova, PD 35126, Italy
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00771784
Lead sponsor
University of Padova
First posted
Oct 13, 2008
Start date
Jul 2008
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Aug 22, 2012

Study contacts

Carlo Ori, Professor
study chair · Department of Pharmacology and Anesthesiology, University of Padova

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion