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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01013298
First received: November 11, 2009
Last updated: November 12, 2009
Last verified: November 2009
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • operative time [ Time Frame: minutes ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01013298

Contacts
Contact: Patrick Sorkine, MD 97236973390 patricks@tasmc.health.gov.il

Locations
Israel
Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel-Aviv, Israel, 64239
Contact: Patrick Sorkine, MD    97236973390    patricks@tasmc.health.gov.il   
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
Investigators
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

No publications provided

Responsible Party: Prof Patrick Sorkine, Intensive Care unit, Tel aviv Sourasky Medical center
ClinicalTrials.gov 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
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Pneumothorax
Mediastinal Emphysema
Pleural Diseases
Respiratory Tract Diseases
Mediastinal Diseases
Thoracic Diseases
Emphysema
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014