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Video-guided Percutaneous Tracheostomy (PCT) Versus Conventional PCT: Comparing Safety and Efficacy

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:
NCT01012518
First received: November 11, 2009
Last updated: November 12, 2009
Last verified: November 2009
History of Changes
  Purpose

The purpose of this study is to compare the feasibility, safety, efficacy and ease of performance of a video-assisted PCT (via an endotracheal tube embedded with a mini video-camera) with the standard ("blind") PCT technique.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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, Compared to Conventional PCT

Resource links provided by NLM:

U.S. FDA Resources

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: 60
Study Start Date: January 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional PCT
PCT performed without video guidance, as conventionally performed
 Device: Standard PCT
The standard technique, performed without video guidance
Other Names:
  • Control
  • Standard PCT
  • Conventional PCT
Experimental: Video-assisted PCT
PCT performed with the guidance of a camera-embedded ETT wired to a monitor
 Device: Video-guided PCT
PCT performed with the guidance of a camera-embedded ETT wired to a monitor
Other Names:
  • Video-guided PCT
  • Video-assisted PCT
  • ETView-guided 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012518

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
Sub-Investigator: Dima Shmain, MD            
Sub-Investigator: Yifat Klein, PhD            
Sub-Investigator: Esther Dahan, MD            
Sub-Investigator: Alex Segerman, MD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Patrick Sorkine, MD Tel-Aviv Sourasky Medical Center
Study Chair: Idit Matot, 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: NCT01012518     History of Changes
Other Study ID Numbers: TASMC-09-PS-0544-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:
Pulmonary Atelectasis
Hemorrhage
Mediastinal Emphysema
Pneumothorax
Anoxia
Lung Diseases
Respiratory Tract Diseases
 Pathologic Processes
Mediastinal Diseases
Thoracic Diseases
Emphysema
Pleural Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013