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

One-Lung Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912598
• Other study ID #: 142/14
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2016
• Last updated: September 22, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Otto-von-Guericke University Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Separation Techniques
• One-Lung Ventilation

Intervention

Device:
• Mallinckrodt™ Endobronchial Tube

• Fuji Uniblocker™

• ETView VivaSight™-SL+EB

• COOK© Arndt Endobronchial Blocker

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otto-von-Guericke University Magdeburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to initial lung isolation	Duration of initial bronchoscopy-guided placement of the endobronchial ballon. Start: Beginning of direct laryngoscopy. End: Initial inflation of the endobronchially placed cuff.	intraoperative	No
Secondary	Ease of placement [numerical rating scale]	Evaluation of difficulty of endobronchial device placement by the anaesthetist.	intraoperative	No
Secondary	Rate of dislocation	Number of device dislocations after correct initial placement. Measurement time point after termination of one-lung ventilation.	intraoperative	No
Secondary	Quality of surgical exposure [numerical rating scale]	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.	intraoperative	No
Secondary	Oxygenation	Measurement of arterial partial pressure of oxygen by blood gas analysis taken 5min and 15min after establishment of one-lung ventilation.	intraoperative	No
Secondary	Bronchoscopies	Number of additional bronchoscopies required after initial placement resulting from suspected or actual dislocations.	intraoperative	No