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"TRAcheostomy With Single Use Bronchoscopes vs. Conventional Bronchoscopes" (TraSUB)

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ClinicalTrials.gov Identifier: NCT03952247
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:

Optical guidance for percutaneous tracheostomy in intensive care is usually performed by conventional multi use bronchoscopy. Recently a single use bronchoscope has been introduced that allows for endotracheal visualization.

For feasibility evaluation, 23 patients in intensive care receive percutaneous tracheostomy with optical guidance by the Ambu® aScopeTM 4 bronchoscope and 23 patients in intensive care receive percutaneous tracheostomy with a conventional bronchoscope (Olympus BF Type P60). The primary end point is the visualization through the single use bronchoscope of endotracheal landmark structures for tracheostomy and visualization of the needle insertion (according to score, see detailed description).


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Single Use Bronchoscopy for PDT Device: Conventional Multi Use Bronchoscopy for PDT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 Single Use Bronchoscopy (TraSUB™)
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Single Use Bronchoscopy
optical guidance of percutaneous tracheotomy is done by single use bronchoscopy
Device: Single Use Bronchoscopy for PDT
optical guidance of percutaneous tracheotomy is done by single use bronchoscopy

Active Comparator: Conventional Multi Use Bronchoscopy
optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy
Device: Conventional Multi Use Bronchoscopy for PDT
optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy




Primary Outcome Measures :
  1. Visualisation [ Time Frame: during tracheotomy ]

    visualisation through the single use bronchoscope of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score) Scale Name: Rating A) Identification of: thyroid cartilage, cricoid cartilage, 1st-3rd tracheal cartilage 1 Reliable identification; 2 Only cricoid cartilage and tracheal cartilages; 3 Only tracheal cartilages; 4 No vision on tracheal structures B) Visualization of tracheal circumference 1 Complete; 2 circumference 1/3 to 2/3 of circumference; 3 Only small parts of trachea; 4 No vision on tracheal structures C) Monitoring puncture: midline + level below 1st or 2nd tracheal cartilage

    1 Reliable identification; 2 Midline sure Level uncertain, but below the 1st tracheal cartilage; 3 Level of puncture uncertain; 4 No vision on tracheal structures D) Monitoring dilatation Anterior wall and Pars membranacea (P.m.) visible; 1 Reliable identification; 2 P.m. only; 3 Only small parts of trachea visible, no control of P.



Secondary Outcome Measures :
  1. Minute ventilation [ Time Frame: two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy ]

    minute ventilation (according to score)

    Scale Name: Quality of Ventilation

    1 Minute ventilation (MV) as before starting tracheotomy; 2 MV < 2 L/min or oxygen saturation (SO2) 80-90% (>2minutes); 3 MV < 0,5l /min or SO2 70 - 79% (> 2 minutes); 4 MV = 0 or SO2 < 70% (> 2 minutes)


  2. Peak airway pressure [ Time Frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula ]

    changes in peak airway pressure of ventilator if volume controlled mode is used

    Measurement during following time Points:

    1. Measurements of Peak airway pressure before sterile drapes are applied; preintervention
    2. Measurement of Changes in Peak airway pressure before Skin incision and during identification of landmark structures
    3. Measure of Peak airway pressure after Insertion of the tracheal canula

  3. pH [ Time Frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula ]

    change in pH-values

    Measurement during following time Points:

    1. Measurements of pH values before sterile drapes are applied; preintervention
    2. Measurement of Changes in pH values before Skin incision and during identification of landmark structures
    3. Measurement of pH values after Insertion of the tracheal canula

  4. paO2 [ Time Frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula ]

    Change in paO2 values

    Measurement during following time Points:

    1. Measurements of paO2 values before sterile drapes are applied; preintervention
    2. Measurement of Changes in paO2 values before Skin incision and during identification of landmark structures
    3. Measurement of paO2 values after Insertion of the tracheal canula

  5. paCO2 [ Time Frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula ]

    Change in paCO2 values

    Measurement during following time Points:

    1. Measurements of paCO2 values before sterile drapes are applied; preintervention
    2. Measurement of Changes in paCO2 values before Skin incision and during identification of landmark structures
    3. Measurement of paCO2 values after Insertion of the tracheal canula

  6. etCO2 [ Time Frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula ]

    Change in etCO2 values

    Measurement during following time Points:

    1. Measurements of etCO2 values before sterile drapes are applied; preintervention
    2. Measurement of Changes in etCO2 values before Skin incision and during identification of landmark structures
    3. Measurement of etCO2 values after Insertion of the tracheal canula

  7. Duration of intervention [ Time Frame: during tracheotomy (skin incision till insertion of tracheal cannula) ]

    Duration of Intervention

    Measurement of Duration of Intervention from Skin incision till Insertion of tracheal cannula (measured in minutes)


  8. Poor visualisation [ Time Frame: during tracheotomy ]

    Poor visualisation with single use bronchoscopy Poor identification thyroid cartilage, cricoid cartilage, 1st-3rd tracheal cartilage : Only identification of tracheal cartilages; No vision possible on tracheal structures Poor visualization of tracheal circumference: Only visualisation of small parts of trachea; No vision on tracheal structures

    Poor monitoring of puncture: midline + level below 1st or 2nd tracheal cartilage

    : Level of puncture uncertain; No vision on tracheal structures Poor Monitoring of Dilatation: Only small parts of trachea visible, no control of P.m.; No vision on tracheal structures


  9. Poor control [ Time Frame: during tracheotomy ]

    Poor control of the single use bronchoscope:

    Intubation of only one bronchial Segment not possible; Intubation of more than one bronchial Segment not possible.


  10. adverse events [ Time Frame: up to 1 week ]
    any adverse events that are likely associated with tracheostomy



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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): NCT03952247


Contacts
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Contact: Jörn Grensemann, MD +49 152 228 24247 j.grensemann@uke.de
Contact: Stefan Kluge, MD, PhD +49 40 7410 ext 57010 s.kluge@uke.de

Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, HH, Germany, 20246
Contact: Stefan Kluge, MD, PhD    +49 40 7410 ext 57010    s.kluge@uke.de   
Contact: Joern Grensemann, MD    +49 152 228 24247    j.grensemann@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Jörn Grensemann, MD Dept. of Intensive Care Medicine

Publications:

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03952247     History of Changes
Other Study ID Numbers: TraSUB
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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