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

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

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery
• Intervention / Treatment: Device: ET View Double Lumen Tube; Device: conventional Double Lumen Tube

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Division of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ET View Double Lumen Tube; Patients assigned to the thisgroup will be intubated using the VivaSight-DL.	Device: ET View Double Lumen Tube; Other Names: VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel)
Active Comparator: conventional Double Lumen Tube; Patients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany).	Device: conventional Double Lumen Tube; Other Names: conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to intubation	Time for intubation, defined as "time from insertion of the laryngoscope until statement of the intubating anesthesiologist, that DLT was correctly placed". Time for intubation will be measured by an independent researcher using a stop watch.	300 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of misplacement	Rate of misplacement, occurring after patients removal from dorsal to lateral position	3 hours
Rate of misplacement	Rate of misplacement, occurring during surgery, potentially caused by vibrations and movements by surgeons	3 hours
Rate of blind insertion	Rate of blind insertion, defined as successful placement of airway device in correct position in trachea/ main stream bronchus without help of fibreoptic bronchoscopy8	300 seconds
rate of fibreoptic bronchoscopy	Necessity of tube re-placement by fibreoptic bronchoscopy	3 hours
Quality of lung collapse		3 hours
Airway injuries		3 hours
Postoperative coughing		24 hours
Postoperative hoarseness		24 hours
Postoperative sore throat		24 hours

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Beatrice Beck Schimmer, Prof MD, University Hospital Zurich, Division of Anaesthesiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2012-0520