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

Phase 4

Completed

• Conditions: Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery
• Interventions: Device: ET View Double Lumen Tube; Device: conventional Double Lumen Tube

• Registration Number: NCT01807676
• Lead Sponsor: University of Zurich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ET View Double Lumen Tube	ET View Double Lumen Tube	Patients assigned to the thisgroup will be intubated using the VivaSight-DL.
conventional Double Lumen Tube	conventional Double Lumen Tube	Patients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany).

Primary Outcome Measures

Name	Time	Method
time to intubation	300 seconds	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich, Division of Anaesthesiology; 🇨🇭 Zurich, ZH, Switzerland