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VivaSight-SL™ Versus Bronchoscopy for Percutaneous Tracheotomy (VivaPDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861001
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:

Optical guidance for percutaneous tracheotomy in intensive care is usually performed by bronchoscopy. Recently, an endotracheal tube with a camera mounted at its tip (VivaSight-SL) has been introduced that allows for endotracheal visualization.

For feasibility evaluation, ten patients in intensive care receive percutaneous tracheotomy with optical guidance by the VivaSight-SL tube. If this part is completed with satisfactory results, patients are randomized to receive optical guidance by bronchoscopy or by VivaSight-SL tube. The primary end point is the visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score, see detailed description).


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: conventional bronchoscopy Device: VivaSight-SL tube Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study in Ventilated Critically Ill Patients Receiving Percutaneous Tracheotomy. A Comparison of Periinterventional Visualization of Conventional Bronchoscopy and an Endotracheal Tube Mounted Camera (VivaSight-SL™)
Study Start Date : April 2016
Actual Primary Completion Date : January 13, 2017
Actual Study Completion Date : January 13, 2017

Arm Intervention/treatment
Active Comparator: bronchoscopic guidance
optical guidance of percutaneous tracheotomy is done by conventional bronchoscopy
Device: conventional bronchoscopy
optical guidance of percutaneous tracheotomy is done by conventional bronchoscopy

Experimental: tube mounted camera guidance
optical guidance of percutaneous tracheotomy is done by the VivaSight-SL tube
Device: VivaSight-SL tube
optical guidance of percutaneous tracheotomy is done by the VivaSight-SL tube




Primary Outcome Measures :
  1. visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score) [ Time Frame: during tracheotomy ]

Secondary Outcome Measures :
  1. minute ventilation according to score generated from 4 point Likert scale at 2 time points [ Time Frame: two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy ]
  2. pulse oxymetric oxygen saturation according to score generated from 4 point Likert scale at 2 time points [ Time Frame: two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy ]
  3. change in pH-values [ Time Frame: three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula ]
  4. change in paCO2 values [ Time Frame: three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula ]
    change in arterial partial pressure of carbon dioxide (mmHg)

  5. change in etCO2 values [ Time Frame: three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula ]
    change in endtidal carbon dioxide (mmHg)

  6. change in paO2 values [ Time Frame: three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula ]
    change in arterial partial pressure of oxygen (mmHg)

  7. changes in peak airway pressure of ventilator [ Time Frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min before insertion of tracheal cannula ]
    if volume controlled mode is used

  8. duration of the intervention [ Time Frame: during tracheotomy ]
  9. adverse events [ Time Frame: up to 1 week ]


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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 percutaneous tracheotomy in the Dept. of Intensive Care Medicine.
  • Age ≥ 18 years
  • Informed consent

Exclusion Criteria:

  • Age < 18 years
  • No consent
  • Direct laryngoscopy according to Cormack-Lehane ≥ 3

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): NCT02861001


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: NCT02861001    
Other Study ID Numbers: VivaPDT
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
tracheotomy
bronchoscopy
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