Endotracheal Intubation
Conditions
Keywords
Endotracheal intubation and its outcomes
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.
Interventions
DEVICEETview TVT endotracheal tube
intubation
DEVICEEndotracheal tube
Intubation
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The induction of general anesthesia, on the operating day (first day) | Time between introducing the laryngoscope and inflation of tube's cuff |
Countries
Israel
Participant flow
Recruitment details
Adult consenting patients that were admitted to Rambam Health Care Campus for laparoscopic sleeve gastrectomy were recruited between February and December 2011
Pre-assignment details
All recruited patients were enrolled in the study, no one was excluded.
Participants by arm
| Arm | Count |
|---|---|
| ETview Endotracheal intubation with ETview TVT
ETview TVT endotracheal tube: intubation | 40 |
| Control Intubation
Endotracheal tube: Intubation | 32 |
| Total | 72 |
Baseline characteristics
| Characteristic | ETview | Control | Total |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 4.9 | 42.5 years STANDARD_DEVIATION 3.2 | 42.8 years STANDARD_DEVIATION 4.1 |
| Sex: Female, Male Female | 26 Participants | 23 Participants | 49 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 32 |
| serious Total, serious adverse events | 0 / 40 | 0 / 32 |
Outcome results
Primary
Duration of Endotracheal Intubation
Time between introducing the laryngoscope and inflation of tube's cuff
Time frame: The induction of general anesthesia, on the operating day (first day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETview | Duration of Endotracheal Intubation | 29 seconds | Standard Deviation 10 |
| Control | Duration of Endotracheal Intubation | 24 seconds | Standard Deviation 8 |
Primary
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