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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

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.


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: VivaSight intubation Device: conventional intubation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2016
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

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




Primary Outcome Measures :
  1. first attempt success rate [ Time Frame: day 1 ]
    after first attempt of intubation

  2. total number of attempts to successful intubation [ Time Frame: day 1 ]
    after successful intubation


Secondary Outcome Measures :
  1. average number of attempts for intubation [ Time Frame: day 1 ]
    after successful intubation

  2. time to successful intubation [ Time Frame: day 1 ]
    after successful intubation

  3. time to successful intubation with one attempt [ Time Frame: day 1 ]
    after first attempt successful intubation, if applicable

  4. vomiting or aspiration during intubation [ Time Frame: day 1 ]
    after successful intubation

  5. accidental esophageal intubation [ Time Frame: day 1 ]
    after successful intubation

  6. decrease of SpO2 < 80% [ Time Frame: day 1 ]
    after successful intubation, SpO2: oxygen saturation by pulse oximetry

  7. hypotension [ Time Frame: day 1 ]
    after successful intubation, hypotension defined as systolic blood pressure < 70mmHg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837055


Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, HH, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Stefan Kluge, MD, PhD Head of Dept. of Intensive Care Medicine
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02837055    
Other Study ID Numbers: VivaITN
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
intubation, intratracheal
critical care
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases