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

Neurological Diseases, Heart or Respiratory Failure, Clinical Trial

Official title:

Effects of Short- and of Long-term Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771784
• Other study ID #: 68144
• Status: Completed
• Phase: N/A
• First received: October 10, 2008
• Last updated: August 21, 2012
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: August 2012
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Diseases
• Nervous System Diseases
• Neurological Diseases, Heart or Respiratory Failure,
• Respiratory Insufficiency
• Sepsis, Trauma.

Locations

Country	Name	City	State
Italy	Intensive Care Unit, S. Anthony Hospital	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory parameters during percutaneous tracheostomy		Thirty minutes.	Yes
Secondary	Scoring of laryngeal lesions, blood gas exchange, morbidity, mortality.		Thirty minutes.	Yes

External Links

•   Link of the Anesthesia and Critical Care Section