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Lung Isolation in Thoracic Surgery - a Randomized Trial Comparing the VivaSight™ EB Endobronchial Blocker With Established Devices

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ClinicalTrials.gov Identifier: NCT02912598
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Tom Kreft, Otto-von-Guericke University Magdeburg

Brief Summary:
Surgery involving the chest cavity, particularly VATS procedures, often require one-lung ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation with different models of bronchial blockers (BB) used in special populations and circumstances. Their routine use is impeded by prolonged placement times, frequent malpositionings and higher costs when compared to the DLT, as recently reported in a meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen tube with an integrated camera and a bronchial blocker allows for endobronchial placement without the use of a fiberoptic bronchoscope. An external monitor provides continuous visualization of the tracheal carina and the position of the bronchial cuff. The purpose of this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to a left-sided double-lumen tube and established bronchial blockers. The investigators hypothesized a reduction in time to initial lung isolation due to the simplified placement procedure compared to other bronchial blockers. Continuous intraprocedural airway visualization may allow for early detection of dislocations. Necessary repositionings may be possible without additional bronchoscopies, reducing both disruptions of ventilation and maintenance costs.

Condition or disease Intervention/treatment Phase
Lung Separation Techniques One-Lung Ventilation Device: Mallinckrodt™ Endobronchial Tube Device: Fuji Uniblocker™ Device: ETView VivaSight™-SL+EB Device: COOK© Arndt Endobronchial Blocker Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Lung Isolation in Thoracic Surgery - a Comparison of the VivaSight™ EB Endobronchial Blocker With Established Devices
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Active Comparator: Mallinckrodt™ Endobronchial Tube
Usage of a left-sided Mallinckrodt™ double-lumen tube (DLT) to achieve lung isolation and one lung ventilation.
Device: Mallinckrodt™ Endobronchial Tube
Active Comparator: Fuji Uniblocker™
Usage of a Fuji Uniblocker™ in a generic single-lumen tube to achieve lung isolation and one lung ventilation.
Device: Fuji Uniblocker™
Experimental: ETView VivaSight™-SL+EB
Usage of a ETView VivaSight™-EB endobronchial blocker in a ETView VivaSight™-SL single-lumen tube to achieve lung isolation and one lung ventilation.
Device: ETView VivaSight™-SL+EB
Active Comparator: COOK© Arndt Endobronchial Blocker
Usage of a COOK© Arndt Endobronchial Blocker in a generic single-lumen tube to achieve lung isolation and one lung ventilation.
Device: COOK© Arndt Endobronchial Blocker



Primary Outcome Measures :
  1. Time to initial lung isolation [ Time Frame: intraoperative ]
    Duration of initial bronchoscopy-guided placement of the endobronchial ballon. Start: Beginning of direct laryngoscopy. End: Initial inflation of the endobronchially placed cuff.


Secondary Outcome Measures :
  1. Ease of placement [numerical rating scale] [ Time Frame: intraoperative ]
    Evaluation of difficulty of endobronchial device placement by the anaesthetist.

  2. Rate of dislocation [ Time Frame: intraoperative ]
    Number of device dislocations after correct initial placement. Measurement time point after termination of one-lung ventilation.

  3. Quality of surgical exposure [numerical rating scale] [ Time Frame: intraoperative ]
    Surgeon's grading of the quality of surgical exposure resulting from lung deflation. Time point is initial view of the thoracic cavity after pleural incision.

  4. Oxygenation [ Time Frame: intraoperative ]
    Measurement of arterial partial pressure of oxygen by blood gas analysis taken 5min and 15min after establishment of one-lung ventilation.

  5. Bronchoscopies [ Time Frame: intraoperative ]
    Number of additional bronchoscopies required after initial placement resulting from suspected or actual dislocations.



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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:

  • age greater than or at 18 years
  • scheduled for elective thoracic surgery with one-lung ventilation
  • written informed consent in anaesthesia, the study and anonymized data collection

Exclusion Criteria:

  • necessary conversion between devices
  • one-lung ventilation impossible to establish
  • denial of the study or data collection
  • surgical or anatomical circumstances preventing the use of a double-lumen tube

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): NCT02912598


Sponsors and Collaborators
Otto-von-Guericke University Magdeburg
Investigators
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Study Chair: Thomas Hachenberg, Prof. Dr. med. Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.
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Responsible Party: Tom Kreft, Principal Investigator, Otto-von-Guericke University Magdeburg
ClinicalTrials.gov Identifier: NCT02912598    
Other Study ID Numbers: 142/14
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016