Study Results
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Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2016-04-30
2018-01-12
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VivaSight intubation
Patients are intubated with the VivaSight-SL endotracheal tube
VivaSight intubation
patients are intubated with an endotracheal tube with an integrated camera
conventional intubation
Patients are intubated with a conventional endotracheal tube
conventional intubation
patients are intubated with a conventional endotracheal tube
Interventions
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VivaSight intubation
patients are intubated with an endotracheal tube with an integrated camera
conventional intubation
patients are intubated with a conventional endotracheal tube
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Informed consent
Exclusion Criteria
* No consent
18 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Stefan Kluge, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Head of Dept. of Intensive Care Medicine
Locations
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Countries
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References
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Braune S, Kluge S. [Airway management]. Dtsch Med Wochenschr. 2014 Oct;139(40):2003-5. doi: 10.1055/s-0034-1387247. Epub 2014 Sep 25. No abstract available. German.
Pothmann W, Kluge S. [Endotracheal intubation]. Dtsch Med Wochenschr. 2010 May;135(3):94-7. doi: 10.1055/s-0029-1244824. Epub 2010 Jan 14. No abstract available. German.
Mosier JM, Whitmore SP, Bloom JW, Snyder LS, Graham LA, Carr GE, Sakles JC. Video laryngoscopy improves intubation success and reduces esophageal intubations compared to direct laryngoscopy in the medical intensive care unit. Crit Care. 2013 Oct 14;17(5):R237. doi: 10.1186/cc13061.
Silverberg MJ, Li N, Acquah SO, Kory PD. Comparison of video laryngoscopy versus direct laryngoscopy during urgent endotracheal intubation: a randomized controlled trial. Crit Care Med. 2015 Mar;43(3):636-41. doi: 10.1097/CCM.0000000000000751.
Huitink JM, Koopman EM, Bouwman RA, Craenen A, Verwoert M, Krage R, Visser IE, Erwteman M, van Groeningen D, Tijink R, Schauer A. Tracheal intubation with a camera embedded in the tube tip (Vivasight() ). Anaesthesia. 2013 Jan;68(1):74-8. doi: 10.1111/anae.12065. Epub 2012 Nov 5.
Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850.
Grensemann J, Eichler L, Wang N, Jarczak D, Simon M, Kluge S. Endotracheal tube-mounted camera-assisted intubation versus conventional intubation in intensive care: a prospective, randomised trial (VivaITN). Crit Care. 2018 Sep 22;22(1):235. doi: 10.1186/s13054-018-2152-4.
Other Identifiers
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VivaITN
Identifier Type: -
Identifier Source: org_study_id
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