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Video-guided Percutaneous Tracheostomy (PCT): A Feasibility Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: November 11, 2009
Last updated: November 12, 2009
Last verified: November 2009
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.

Condition Intervention
Bleeding Hypoxia Atelectasis Pneumothorax Pneumomediastinum Device: video-guided PCT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Video-guided Percutaneous Tracheostomy (PCT): Evaluating the Safety, Efficacy and Simplicity of a Novel Technique

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • procedure-related complications [ Time Frame: 6h ]

Secondary Outcome Measures:
  • operative time [ Time Frame: minutes ]

Estimated Enrollment: 10
Study Start Date: January 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Video-guided PCT
Patients that will be extubated and re-intubated with the ETT-TVT, and monitored throughout intubation and PCT
Device: video-guided PCT
extubation and then re-intubation with the ETT-TVT, followed by video monitoring of the PCT procedure via the ETT-TVT
Other Name: monitored PCT

  Show Detailed Description


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01013298

Contact: Patrick Sorkine, MD 97236973390

Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel-Aviv, Israel, 64239
Contact: Patrick Sorkine, MD    97236973390   
Sub-Investigator: Yifat Klein, PhD         
Sub-Investigator: Esther Dahan, MD         
Principal Investigator: Dima Shmain, MD         
Sub-Investigator: Alex Segerman, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Study Director: Patrick Sorkine, MD Tel-Aviv Sourasky Medical Center
Study Chair: Idit Matot, MD Tel-Aviv Sourasky Medical Center
Principal Investigator: Dima Shmain, MD Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Prof Patrick Sorkine, Intensive Care unit, Tel aviv Sourasky Medical center Identifier: NCT01013298     History of Changes
Other Study ID Numbers: TASMC-09-PS-0543-CTIL
Study First Received: November 11, 2009
Last Updated: November 12, 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
percutaneous tracheostomy
paratracheal insertion
tracheal injury
transtracheal needle
ventilatory parameters

Additional relevant MeSH terms:
Pulmonary Atelectasis
Mediastinal Emphysema
Pleural Diseases
Respiratory Tract Diseases
Lung Diseases
Mediastinal Diseases
Thoracic Diseases
Pathologic Processes processed this record on September 21, 2017