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

NCT02912598 | Completed Phase 4

• 1 other identifier: 142/14
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Separation Techniques; One-Lung Ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Ease of placement [numerical rating scale]

  intraoperative

• Rate of dislocation

  intraoperative

• Quality of surgical exposure [numerical rating scale]

  intraoperative

• Oxygenation

  intraoperative

• Bronchoscopies

  intraoperative

Study Arms (4)

Mallinckrodt™ Endobronchial Tube

ACTIVE COMPARATOR

Usage of a left-sided Mallinckrodt™ double-lumen tube (DLT) to achieve lung isolation and one lung ventilation.

Device: Mallinckrodt™ Endobronchial Tube

Fuji Uniblocker™

ACTIVE COMPARATOR

Usage of a Fuji Uniblocker™ in a generic single-lumen tube to achieve lung isolation and one lung ventilation.

Device: Fuji Uniblocker™

ETView VivaSight™-SL+EB

EXPERIMENTAL

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

COOK© Arndt Endobronchial Blocker

ACTIVE COMPARATOR

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

Interventions

Mallinckrodt™ Endobronchial Tube DEVICE

Mallinckrodt™ Endobronchial Tube

Fuji Uniblocker™ DEVICE

Fuji Uniblocker™

ETView VivaSight™-SL+EB DEVICE

ETView VivaSight™-SL+EB

COOK© Arndt Endobronchial Blocker DEVICE

COOK© Arndt Endobronchial Blocker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otto-von-Guericke University Magdeburg: lead

Study Officials

• Thomas Hachenberg, Prof. Dr. med.

  Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 23, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-09