NCT02837055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

June 13, 2016

Last Update Submit

January 19, 2018

Conditions

Respiratory Insufficiency

Keywords

intubation, intratrachealcritical care

Outcome Measures

Primary Outcomes (2)

  • first attempt success rate

    after first attempt of intubation

    day 1

  • total number of attempts to successful intubation

    after successful intubation

    day 1

Secondary Outcomes (7)

  • average number of attempts for intubation

    day 1

  • time to successful intubation

    day 1

  • time to successful intubation with one attempt

    day 1

  • vomiting or aspiration during intubation

    day 1

  • accidental esophageal intubation

    day 1

  • +2 more secondary outcomes

Study Arms (2)

VivaSight intubation

EXPERIMENTAL

Patients are intubated with the VivaSight-SL endotracheal tube

Device: VivaSight intubation

conventional intubation

ACTIVE COMPARATOR

Patients are intubated with a conventional endotracheal tube

Device: conventional intubation

Interventions

VivaSight intubationDEVICE

patients are intubated with an endotracheal tube with an integrated camera

VivaSight intubation
conventional intubationDEVICE

patients are intubated with a conventional endotracheal tube

conventional intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years
  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Related Publications (7)

  • 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.

    PMID: 25254395BACKGROUND

  • 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.

    PMID: 20077384BACKGROUND

  • 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.

    PMID: 24125064BACKGROUND

  • 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.

    PMID: 25479112BACKGROUND

  • 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.

    PMID: 23121322BACKGROUND

  • 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.

    PMID: 26020389BACKGROUND

  • 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.

    PMID: 30241488DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Stefan Kluge, MD, PhD

    Head of Dept. of Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

July 19, 2016

Study Start

April 1, 2016

Primary Completion

January 12, 2018

Study Completion

January 12, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)