Conventional Intubation Versus VivaSight™-SL (VivaITN)

January 19, 2018 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • HH
      • Hamburg, HH, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VivaSight intubation
Patients are intubated with the VivaSight-SL endotracheal tube
Device: VivaSight intubation
patients are intubated with an endotracheal tube with an integrated camera
Active Comparator: conventional intubation
Patients are intubated with a conventional endotracheal tube
Device: conventional intubation
patients are intubated with a conventional endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first attempt success rate
Time Frame: day 1
after first attempt of intubation
day 1
total number of attempts to successful intubation
Time Frame: day 1
after successful intubation
day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Stefan Kluge, MD, PhD, Head of Dept. of Intensive Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VivaITN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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