Tracheostomy in ICU With a Double Lumen Endotracheal Tube

Not Applicable

• Conditions: Neurological Disease; Acute Respiratory Failure; Heart Failure
• Interventions: Device: Double lumen endotracheal tube tracheostomy

• Registration Number: NCT01691222
• Lead Sponsor: University of Genova

Brief Summary

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:

1. improve the ventilation of patients during the procedure,

2. protect the posterior tracheal wall from damage related to the different step of tracheostomies,

3. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-24
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-02
• Last Update Posted: 2013-07-03
• Primary Completion: 2014-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age ≥ 18 years and at least one of following criteria:
• prolonged endotracheal intubation
• prolonged mechanical ventilation
• difficult/prolonged weaning
• inability to protect the airway

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Exclusion Criteria

• infection of neck tissues
• previous surgical neck interventions
• recent surgical interventions or fracture of the cervical spine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double lumen endotracheal tube tracheostomy	Double lumen endotracheal tube tracheostomy	Tracheostomy with a dedicated double lumen endotracheal tube

Primary Outcome Measures

Name	Time	Method
change in gas-exchange	at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)	The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio

Secondary Outcome Measures

Name	Time	Method
early complications	in the first 24 hours from the end of the procedure	early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax,
change in air-trapping	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)	the investigator will record auto-PEEP at the of expiration as a measure of air-trapping
change in peak airway pressure	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)	the investigator will record peak airway pressure
change in plateau airway pressure	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)	the investigator will record plateau airway pressure
change in arterial carbon dioxide	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)	the investigator will perform an arterial blood gas to evaluate PaCO2
late complications	from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)	late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.

Trial Locations

Locations (2)

University of Genoa; 🇮🇹 Genoa, Italy

University of Naples "Federico II"; 🇮🇹 Naples, Italy