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Completed

NCT Number: NCT02912598

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mallinckrodt™ Endobronchial Tube

Device

Fuji Uniblocker™

Device

ETView VivaSight™-SL+EB

Device

COOK© Arndt Endobronchial Blocker

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Otto-von-Guericke University Magdeburg

Other

Registry information

Official study title

Lung Isolation in Thoracic Surgery - a Comparison of the VivaSight™ EB Endobronchial Blocker With Established Devices

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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