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

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

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 laryngoscopy , or catecholamines 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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Device: ETview TVT endotracheal tube; Device: Endotracheal tube

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ETview; ETview TVT endotracheal tube	Device: ETview TVT endotracheal tube; intubation
SHAM_COMPARATOR: Control; Endotracheal tube	Device: Endotracheal tube; Intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube		1 year
Duration of Endotracheal Intubation	Time between introducing the laryngoscope and inflation of tube's cuff	The induction of general anesthesia, on the operating day (first day)

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Michal Barak, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: January 17, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (ESTIMATE): January 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 27, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Endotracheal intubation and its outcomes
• Other Study ID Numbers: 181-09CTIL; 0181-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED