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

Endotracheal Intubation Clinical Trial

Official title:

Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation During Regular and Difficult Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279564
• Other study ID #: 181-09CTIL
• Secondary ID: 0181
• Status: Completed
• Phase: N/A
• First received: January 17, 2011
• Last updated: November 4, 2014
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2011
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Device:
• ETview TVT endotracheal tube
intubation
• Endotracheal tube
Intubation

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube		1 year	No
Primary	Duration of Endotracheal Intubation	Time between introducing the laryngoscope and inflation of tube's cuff	Endotracheal intubation	No