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

NCT01279564 | Completed Results DMC

• 2 other identifiers: 181-09CTIL0181-RMB
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Endotracheal Intubation

Keywords

Endotracheal intubation and its outcomes

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

ETview

EXPERIMENTAL

ETview TVT endotracheal tube

Device: ETview TVT endotracheal tube

Control

SHAM COMPARATOR

Endotracheal tube

Device: Endotracheal tube

Interventions

ETview TVT endotracheal tube DEVICE

intubation

ETview

Endotracheal tube DEVICE

Intubation

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Results Point of Contact

• Title: Dr. Michal Barak
• Organization: Rambam Health Care Campus

m_barak@rambam.health.gov.il

972 4 8542487

Study Officials

• Michal Barak, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 27, 2016
• Results First Posted: November 11, 2014

Record last verified: 2016-06

Locations

IL (1)