Suspended

Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube

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What is being tested

Double lumen endotracheal tube tracheostomy

Device
Who is being recruted

Cardiovascular Diseases+1

+ Heart Diseases

+ Heart Failure

From 18 to 82 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorUniversity of Genova
Study ContactPaolo Pelosi, ProfessorMore contacts
Last updated: July 3, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. This situation may lead to many disadvantages for ventilation and airway protection of critically ill patients during the procedures. The use of double lumen endotracheal tube dedicated to the percutaneous tracheostomies may: improve the ventilation of patients during the procedure, protect the posterior tracheal wall from damage related to the different step of tracheostomies, protect the lungs from blood and secretions coming down from the chosen site of tracheostomy. So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen endotracheal tube.

NCT01691222
Principal SponsorUniversity of Genova
Study ContactPaolo Pelosi, ProfessorMore contacts
Last updated: July 3, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 82 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart FailureNervous System Diseases

Criteria

5 inclusion criteria required to participate
age >= 18 years and at least one of following criteria
difficult/prolonged weaning
inability to protect the airway
prolonged endotracheal intubation
Show More Criteria
3 exclusion criteria prevent from participating
infection of neck tissues
previous surgical neck interventions
recent surgical interventions or fracture of the cervical spine

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Tracheostomy with a dedicated double lumen endotracheal tube

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

University of Genoa

Genoa, ItalyOpen University of Genoa in Google Maps
Recruiting

University of Naples "Federico II"

Naples, Italy
Suspended2 Study Centers