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Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Michal Barak, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01279564
First received: January 17, 2011
Last updated: November 4, 2014
Last verified: February 2011
  Purpose

Airway management is one of the most important tasks facing the physician, especially the anesthesiologist. Fast and correct performance of endotracheal intubations done as normal routine in the operating room, but can save life everywhere.

To make intubation easier, several newly designed tubes and laryngoscopes are developed and tested every year. Their performance is evaluated subjectively by the acting anesthesiologist, and by using objective parameters such as speed of intubation, the force applied during latyngoscopy , or catecholeamines secretion during intubation as a stress parameter . The studies set for testing these parameters lead to establish accepted indications for the treatment of the airway in cases of anticipated and unanticipated difficult airway.

In the present study we will compare the performance parameters of intubation using Etview Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer dimensions and material is exactly as the standard tube, the difference is only the inner fiber of the camera.


Condition Intervention
Endotracheal Intubation
Device: ETview TVT endotracheal tube
Device: Endotracheal tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation During Regular and Difficult Intubation

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Duration of Endotracheal Intubation [ Time Frame: Endotracheal intubation ] [ Designated as safety issue: No ]
    Time between introducing the laryngoscope and inflation of tube's cuff


Enrollment: 72
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETview
Endotracheal intubation with ETview TVT
Device: ETview TVT endotracheal tube
intubation
Sham Comparator: Control
Intubation
Device: Endotracheal tube
Intubation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients scheduled for elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

  • Age under 18 years
  • ASA greater than 3
  • Lip, oral or airway infection
  • Coagulopathy
  • Indication to perform Sellick`s maneuver for increased risk of aspiration
  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: NCT01279564

Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Dr Michal Barak, Anesthesiologist, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01279564     History of Changes
Other Study ID Numbers: 181-09CTIL, 0181
Study First Received: January 17, 2011
Results First Received: November 4, 2014
Last Updated: November 4, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Endotracheal intubation and its outcomes

ClinicalTrials.gov processed this record on November 27, 2014