Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube

NCT ID: NCT01807676

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-03-31

Brief Summary

No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT.

• Trial with medical device

Detailed Description

In several clinical situations and surgical procedures single-lung ventilation (SLV) is essential. Especially during thoracic surgery SLV and collapse of the operated lung, while ventilating the other side of the lung is the most frequented indication. In these cases the double lumen tube (DLT) is the most widely used device.

The DLT consists of a proximal tracheal and a distal bronchial end, reaching into the left or the right side of the lung- dependent of the model of the tube. Endotracheal intubation with DLT, which are much larger and stiffer than conventional single-lumen tubes, are much more difficult to place and are especially likely to provoke airway injuries. Furthermore, placement of a DLT requires obligatory fiberoptic bronchoscopy and a certain level of experience. Tube misplacement after patients removal from dorsal (intubation-) to lateral position as well as during surgical procedure is relatively frequent. Tube displacement from its proper position above the carina, respectively in the main bronchus, may result in life-threating complications and airway lacerations.

The anesthetist may detect tube misplacement from indirect clinical signs including increased airway pressure, oxygen desaturation, or difficulty performing SLV. In this clinical situations, verification of tube position using fibreoptic bronchoscopy is indicated. Fibreoptic bronchoscopy requires rigorous training and practice to maintain a high level of skill as well as expensive infrastructure.

The VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) is a new DLT promising to exceed clinical performance of the conventional DLT. The VivaSight-DL is basically a left-sided DLT with an embedded video imaging device and light source at its tip and integrated cable with connector. However, after correct tube placement, the video imaging device is focused on the main carina, indicating the correct position of the bronchial cuff in the left main bronchus.

Conditions

Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ET View Double Lumen Tube

Patients assigned to the thisgroup will be intubated using the VivaSight-DL.

Group Type: ACTIVE_COMPARATOR

ET View Double Lumen Tube

Intervention Type: DEVICE

conventional Double Lumen Tube

Patients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany).

Group Type: ACTIVE_COMPARATOR

conventional Double Lumen Tube

Intervention Type: DEVICE

Interventions

ET View Double Lumen Tube

Intervention Type: DEVICE

conventional Double Lumen Tube

Intervention Type: DEVICE

Other Intervention Names

VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel); conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany)

Eligibility Criteria

Inclusion Criteria

• Elective thoracic surgery with anticipated use of a DLT
• Anticipated extubation in the operating room;
• American Society of Anesthesiologist Physical Status 1-3;
• Age 18- 90.
• Written consent (signature from patient)

Exclusion Criteria

• Tracheal pathology, including tracheostomy;
• Any form of infection (including upper-respiratory tract infection or pneumonia) or suspected tuberculosis;
• BMI higher exceeding 40 kg/m2;
• Known or suspected difficult airway.
• Pregnancy
• Breast feeding
• The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatrice Beck Schimmer, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Anaesthesiology

Locations

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

Schuepbach R, Grande B, Camen G, Schmidt AR, Fischer H, Sessler DI, Seifert B, Spahn DR, Ruetzler K. Intubation with VivaSight or conventional left-sided double-lumen tubes: a randomized trial. Can J Anaesth. 2015 Jul;62(7):762-9. doi: 10.1007/s12630-015-0329-8. Epub 2015 Feb 6.

Reference Type: DERIVED

PMID: 25663254 (View on PubMed)

Other Identifiers

2012-0520

Identifier Type: -

Identifier Source: org_study_id