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Conventional Intubation Versus VivaSight™-SL (VivaITN)

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ClinicalTrials.gov Identifier: NCT02837055
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE June 13, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE April 2016
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • first attempt success rate [ Time Frame: day 1 ]
    after first attempt of intubation
  • total number of attempts to successful intubation [ Time Frame: day 1 ]
    after successful intubation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • average number of attempts for intubation [ Time Frame: day 1 ]
    after successful intubation
  • time to successful intubation [ Time Frame: day 1 ]
    after successful intubation
  • time to successful intubation with one attempt [ Time Frame: day 1 ]
    after first attempt successful intubation, if applicable
  • vomiting or aspiration during intubation [ Time Frame: day 1 ]
    after successful intubation
  • accidental esophageal intubation [ Time Frame: day 1 ]
    after successful intubation
  • decrease of SpO2 < 80% [ Time Frame: day 1 ]
    after successful intubation, SpO2: oxygen saturation by pulse oximetry
  • hypotension [ Time Frame: day 1 ]
    after successful intubation, hypotension defined as systolic blood pressure < 70mmHg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conventional Intubation Versus VivaSight™-SL
Official Title  ICMJE Prospective, Randomized Study in Critically Ill Patients Receiving Endotracheal Intubation: Comparison Between a Conventional Approach and Video Assisted Intubation by the VivaSight™-SL Tube
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Insufficiency
Intervention  ICMJE
  • Device: VivaSight intubation
    patients are intubated with an endotracheal tube with an integrated camera
  • Device: conventional intubation
    patients are intubated with a conventional endotracheal tube
Study Arms  ICMJE
  • Experimental: VivaSight intubation
    Patients are intubated with the VivaSight-SL endotracheal tube
    Intervention: Device: VivaSight intubation
  • Active Comparator: conventional intubation
    Patients are intubated with a conventional endotracheal tube
    Intervention: Device: conventional intubation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2016)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 12, 2018
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02837055
Other Study ID Numbers  ICMJE VivaITN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Kluge, MD, PhD Head of Dept. of Intensive Care Medicine
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP