Clinical trial NCT02837055: Conventional Intubation Versus VivaSight™-SL
Official title: Prospective, Randomized Study in Critically Ill Patients Receiving Endotracheal Intubation: Comparison Between a Conventional Approach and Video Assisted Intubation by the VivaSight™-SL Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: intubation, intratracheal
critical care
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: first attempt success rate
timeFrame: day 1
measure: total number of attempts to successful intubation
timeFrame: day 1
Secondary outcomes:
measure: average number of attempts for intubation
timeFrame: day 1
measure: time to successful intubation
timeFrame: day 1
measure: time to successful intubation with one attempt
timeFrame: day 1
measure: vomiting or aspiration during intubation
timeFrame: day 1
measure: accidental esophageal intubation
timeFrame: day 1
measure: decrease of SpO2 < 80%
timeFrame: day 1
measure: hypotension
timeFrame: day 1
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
state: HH
Study officials:
affiliation: Head of Dept. of Intensive Care Medicine
name: Stefan Kluge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.