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

NCT ID: NCT01279564

Last Updated: 2016-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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ETview

ETview TVT endotracheal tube

Group Type EXPERIMENTAL

ETview TVT endotracheal tube

Intervention Type DEVICE

intubation

Control

Endotracheal tube

Group Type SHAM_COMPARATOR

Endotracheal tube

Intervention Type DEVICE

Intubation

Interventions

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ETview TVT endotracheal tube

intubation

Intervention Type DEVICE

Endotracheal tube

Intubation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michal Barak, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0181-RMB

Identifier Type: -

Identifier Source: secondary_id

181-09CTIL

Identifier Type: -

Identifier Source: org_study_id

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