Conventional Intubation Versus VivaSight™-SL

Study Overview
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Brief Summary
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It has been shown that videolaryngoscopy may be superior to direct laryngoscopy for endotracheal intubation in intensive care. Recently, an endotracheal tube with an integrated camera at its tip has been introduced (VivaSight-SL) allowing for direct visual confirmation of the tube's passage through the vocal cords during intubation. Patients who are requiring urgent or endotracheal intubation in intensive care are randomized to receive either a conventional intubation with direct laryngoscopy or to receive intubation with the VivaSight-SL-Tube. Primary outcome measures are first attempt success rate and number of attempts to successful intubation.

Detailed Description
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Background Airway management in critically ill patients is usually performed by endotracheal intubation with direct laryngoscopy. [1, 2] However, it has been shown that videolaryngoscopy may be superior to the conventional approach in intensive care, i. e. the number of attempts to successful intubation and the rate of accidental esophageal intubation are lower and the visualization of the vocal chords is improved. [3, 4] Recently, an endotracheal tube with an integrated camera at its tip has been introduced that permits a continuous visualization of the tube's insertion into the trachea on a monitor connected to the camera (VivaSightTM-SL, ETView Ltd., Misgav, Israel) [5]. This tube has been CE and FDA certified (http://www.etview.com/products/vivasight-sl). It is possible to observe the passage of the tube through the vocal chords during intubation and to verify the correct placement by visualization of the tracheal cartilage. This is an advantage over videolaryngoscopy, in which the camera is mounted on the laryngoscope blade. For the VivaSightTM-SL tube, a decrease for time to intubation and an increase of first attempt success has been shown over conventional intubation in a simulator trial. [6] In this study, the VivaSightTM-SL tube is tested against the conventional approach during elective and urgent intubations in critically ill patients. Methods Study design: randomized, prospective trial Sample size: n = 54 With a sample size of 54 (randomized 1:1 as 2x 27) a difference of 35% for first attempt success over conventional intubation may be detected with an α-error of 0,05 and a β-error of 1-0,8. Duration of study: until sample size reached or 18 months after begin of study Procedures: screening of patients for study inclusion according to inclusion and exclusion criteria conventional endotracheal intubation by direct laryngoscopy endotracheal intubation with the VivaSightTM-SL tube study inclusion: All patients being treated in the Dept. of Intensive Care Medicine receiving percutaneous tracheotomy due to long term ventilation are screened according to inclusion and exclusion criteria. Details of study related procedures: Intubation: The Intubation with the VivaSightTM-SL endotracheal tube does not differ from an intubation with a conventional tube that is done with respect to the standard operating procedure (SOP) of the Dept. of Intensive Care Medicine. Additionally, the intubation is guided by the camera mounted on the tip of the tube. During the intubation, vital parameters are monitored with respect to the underlying disease and patients' therapy is continuously adjusted. According to the SOP, two physicians are present of which at least one is a fellow or an attending physician with experience in intensive care medicine. In this trial, intubation is done exclusively by a fellow or attending physician. Consent: all patients or their legal surrogate give written informed consent. Data protection: Data are anonymized.

Official Title
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Prospective, Randomized Study in Critically Ill Patients Receiving Endotracheal Intubation: Comparison Between a Conventional Approach and Video Assisted Intubation by the VivaSight™-SL Tube

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: VivaSight intubation
* Device: conventional intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving urgent or elective endotracheal intubation in the Dept. of Intensive Care Medicine. Age ≥ 18 years Informed consent Exclusion Criteria: Age < 18 years No consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VivaSight intubation<br>Patients are intubated with the VivaSight-SL endotracheal tube | Device: VivaSight intubation<br>* patients are intubated with an endotracheal tube with an integrated camera<br>|
| Active Comparator: conventional intubation<br>Patients are intubated with a conventional endotracheal tube | Device: conventional intubation<br>* patients are intubated with a conventional endotracheal tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first attempt success rate | after first attempt of intubation | day 1 | 
| total number of attempts to successful intubation | after successful intubation | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average number of attempts for intubation | after successful intubation | day 1 | 
| time to successful intubation | after successful intubation | day 1 | 
| time to successful intubation with one attempt | after first attempt successful intubation, if applicable | day 1 | 
| vomiting or aspiration during intubation | after successful intubation | day 1 | 
| accidental esophageal intubation | after successful intubation | day 1 | 
| decrease of SpO2 < 80% | after successful intubation, SpO2: oxygen saturation by pulse oximetry | day 1 | 
| hypotension | after successful intubation, hypotension defined as systolic blood pressure < 70mmHg | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, intratracheal, critical care