Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation
Recruitment status was Not yet recruiting
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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 |
- 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 ]
- Intubation time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | January 2012 (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 |
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| Israel | |
| Rambam Health Care Campus | Not yet recruiting |
| Haifa, Israel | |
| Contact: Michal Barak, MD 972 4 854 2487 m_barak@rambam.health.gov.il | |
| Principal Investigator: Michal Barak, MD | |
More Information
No publications provided
| Responsible Party: | Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01279564 History of Changes |
| Other Study ID Numbers: | 181-09CTIL, 0181 |
| Study First Received: | January 17, 2011 |
| Last Updated: | January 18, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rambam Health Care Campus:
|
Endotracheal intubation and its outcomes |
ClinicalTrials.gov processed this record on June 18, 2013