Conventional Intubation Versus VivaSight™-SL

Respiratory Insufficiency Clinical Trial

— VivaITN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837055
• Other study ID #: VivaITN
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: January 19, 2018
• Start date: April 2016
• Est. completion date: January 12, 2018

Study information

• Verified date: January 2018
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• VivaSight intubation
patients are intubated with an endotracheal tube with an integrated camera
• conventional intubation
patients are intubated with a conventional endotracheal tube

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg	HH

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. Review. German. — View 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. — View 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. Erratum in: Medicine (Baltimore). 2015 Jun;94(25):1. — View 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. — View 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. German. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first attempt success rate	after first attempt of intubation	day 1
Primary	total number of attempts to successful intubation	after successful intubation	day 1
Secondary	average number of attempts for intubation	after successful intubation	day 1
Secondary	time to successful intubation	after successful intubation	day 1
Secondary	time to successful intubation with one attempt	after first attempt successful intubation, if applicable	day 1
Secondary	vomiting or aspiration during intubation	after successful intubation	day 1
Secondary	accidental esophageal intubation	after successful intubation	day 1
Secondary	decrease of SpO2 < 80%	after successful intubation, SpO2: oxygen saturation by pulse oximetry	day 1
Secondary	hypotension	after successful intubation, hypotension defined as systolic blood pressure < 70mmHg	day 1