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Respiratory InsufficiencyVivaITNNCT02837055

Conventional Intubation Versus VivaSight™-SL

A study testing VivaSight intubation and conventional intubation in people with Respiratory Insufficiency, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Insufficiency
What is being tested?
VivaSight intubation and conventional intubation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteGermany
Study dates
Apr 2016to 12 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients receiving urgent or elective endotracheal intubation in the Dept. of Intensive Care Medicine.
  • Age ≥ 18 years
  • Informed consent

Who cannot join

  • Age < 18 years
  • No consent

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
VivaSight intubation, conventional intubation
Keywords
intubation, intratracheal, critical care
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VivaSight intubationDevice

    patients are intubated with an endotracheal tube with an integrated camera

  • conventional intubationDevice

    patients are intubated with a conventional endotracheal tube

Study groups in NCT02837055
Study groupRoleWhat they receive
VivaSight intubationExperimentalPatients are intubated with the VivaSight-SL endotracheal tube
Receives: Device: VivaSight intubation
conventional intubationActive comparatorPatients are intubated with a conventional endotracheal tube
Receives: Device: conventional intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. first attempt success rate

    after first attempt of intubation

    Measured: day 1

  2. total number of attempts to successful intubation

    after successful intubation

    Measured: day 1

Secondary outcomes (7)

  1. average number of attempts for intubation

    after successful intubation

    Measured: day 1

  2. time to successful intubation

    after successful intubation

    Measured: day 1

  3. time to successful intubation with one attempt

    after first attempt successful intubation, if applicable

    Measured: day 1

  4. vomiting or aspiration during intubation

    after successful intubation

    Measured: day 1

  5. accidental esophageal intubation

    after successful intubation

    Measured: day 1

  6. decrease of SpO2 < 80%

    after successful intubation, SpO2: oxygen saturation by pulse oximetry

    Measured: day 1

  7. hypotension

    after successful intubation, hypotension defined as systolic blood pressure < 70mmHg

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion12 Jan 2018
  4. Study completion12 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837055
Sponsor's protocol ID
VivaITN
Acronym
VivaITN
Status last verified
Jan 2018
First submitted
13 Jun 2016
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25254395

  • 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.

    PubMed 20077384

  • 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.

    PubMed 24125064

  • 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.

    PubMed 25479112

  • 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.

    PubMed 23121322

  • 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.

    PubMed 26020389

  • 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.

    PubMed 30241488

Questions about this trial

What is this clinical trial studying?

A study testing VivaSight intubation and conventional intubation in people with Respiratory Insufficiency, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

first attempt success rate (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02837055, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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