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| ID | Type | Description | Link |
|---|---|---|---|
| 0181-RMB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETview | Experimental | ETview TVT endotracheal tube |
|
| Control | Sham Comparator | Endotracheal tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETview TVT endotracheal tube | Device | intubation |
| |
| Endotracheal tube |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Barak, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | Israel |
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All recruited patients were enrolled in the study, no one was excluded.
Adult consenting patients that were admitted to Rambam Health Care Campus for laparoscopic sleeve gastrectomy were recruited between February and December 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | ETview | Endotracheal intubation with ETview TVT ETview TVT endotracheal tube: intubation |
| FG001 | Control | Intubation Endotracheal tube- standard |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ETview | Endotracheal intubation with ETview TVT ETview TVT endotracheal tube: intubation |
| BG001 | Control | Intubation Endotracheal tube: Intubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube | Not Posted | 1 year | |||||||||||||
| Primary | Duration of Endotracheal Intubation | Time between introducing the laryngoscope and inflation of tube's cuff | Posted | Mean | Standard Deviation | seconds | The induction of general anesthesia, on the operating day (first day) |
1 year
No adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ETview | Endotracheal intubation with ETview TVT ETview TVT endotracheal tube: intubation No adverse events |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Difficult intubation or ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Difficulties in introducing the endotracheal tube or ventilating the patient |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michal Barak | Rambam Health Care Campus | 972 4 8542487 | m_barak@rambam.health.gov.il |
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| Device |
Intubation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Control | Intubation Endotracheal tube: Intubation No adverse events | 0 | 32 | 0 | 32 |
|
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