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Clinical Trials/NCT01013298
NCT01013298UnknownNot Applicable

Video-guided Percutaneous Tracheostomy (PCT): Evaluating the Safety, Efficacy and Simplicity of a Novel Technique

Tel-Aviv Sourasky Medical Center1 site in 1 country10 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
10
Locations
1
Primary Endpoint
procedure-related complications

Study Overview

Brief Summary

The purpose of this study is to determine the feasibility, safety and effectiveness of an endotracheal tube embedded with a mini video-camera as a guiding tool for percutaneous tracheostomy.

Detailed Description

Background

Percutaneous tracheostomy (PCT) is commonly used in the intensive care unit (ICU) for critically-ill patients who require long-term mechanical ventilation. In experienced hands, and with proper patient selection, it is safe, easy and quick, and the associated perioperative complication rate can be reduced to approximately 4% [1-7]. However, skilled intensivist may not always be available, and the procedure may sometimes entail complications. These include paratracheal insertion of the tracheostomy tube, tracheal injury; puncturing the cuff and transfixing the endotracheal tube (ETT) during the transtracheal needle insertion; inserting the guide wire through Murphy's eye; or accidental extubation while withdrawing the endotracheal tube during the procedure leading to loss of the airway [8-13].

Although using the fingertip to palpate the trachea and endotracheal tube is a useful technique to locate the tip of the endotracheal tube during the procedure, it is unreliable, particularly in patients with short and thick necks. Bronchoscopic guidance of PCT is generally recommended to minimize the risk of unintentional tracheal injury. The use of a fibreoptic bronchoscope may be helpful [14-18]. However, it is an expensive tool which is not readily available in some centers. Video guidance provides a cost-effective alternative to bronchoscopes, that may also reduce the risk of procedure-related complications such as paratracheal insertion of the tracheostomy tube, tracheal injury or cuff puncture [19].

The goal of this study is to observe and describe a simple and safe technique - Video-guided PCT - that may overcome some of the limitations of percutaneous tracheostomy, to report any potentially-related complications that may occur during or after the procedure, and to portray a learning curve obtained with this technique.

The equipment used for this technique is the ETView TVTTM, a commercially available ETT, embedded with a mini video-camera at the tip of the tube. It provides direct endoscopic visualization of the larynx and tracheal mucosa, and thereafter allows the determination of the tip of the transtracheal needle during percutaneous puncture of the trachea, and hence may reduce the likelihood of paratracheal insertion, tracheal injury, or other technical complications.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The investigators will enroll for this study
  • •patients aged > 18 years old, admitted to the ICU,
  • •who require elective PCT for prolonged mechanical ventilation, airway protection or weaning failure.

Exclusion Criteria

  • •Patients indicated for surgical tracheostomy, due to altered or difficult local anatomy;
  • •necessity of emergency airway access due to acute airway compromise;
  • •evidence of infection in the soft tissues of the neck;
  • •coagulation abnormalities (INR>1.5, PTT>40, thrombocyte count < 50,000);
  • •gross distortion of the neck anatomy (due to hematoma/tumor/thyromegaly/scarring from previous neck surgery/ unstable C-spine);
  • •contra-indication for re-intubation/suspected loss of airway during re-intubation;
  • •hemodynamic instability.

Arms & Interventions

Video-guided PCT

Experimental

Patients that will be extubated and re-intubated with the ETT-TVT, and monitored throughout intubation and PCT

Intervention: video-guided PCT (Device)

Outcomes

Primary Outcomes

procedure-related complications

Time Frame: 6h

Secondary Outcomes

  • operative time(minutes)

Investigators

Sponsor Class
Other Gov

Study Sites (1)

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