Clinical trial NCT01807676: Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
Official title: Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: time to intubation
timeFrame: 300 seconds
Secondary outcomes:
measure: Rate of misplacement
timeFrame: 3 hours
measure: Rate of misplacement
timeFrame: 3 hours
measure: Rate of blind insertion
timeFrame: 300 seconds
measure: rate of fibreoptic bronchoscopy
timeFrame: 3 hours
measure: Quality of lung collapse
timeFrame: 3 hours
measure: Airway injuries
timeFrame: 3 hours
measure: Postoperative coughing
timeFrame: 24 hours
measure: Postoperative hoarseness
timeFrame: 24 hours
measure: Postoperative sore throat
timeFrame: 24 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Anaesthesiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Anaesthesiology
name: Beatrice Beck Schimmer, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.