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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807676
• Other study ID #: 2012-0520
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2013
• Last updated: April 25, 2014
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• ET View Double Lumen Tube

• conventional Double Lumen Tube

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Anaesthesiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Rate of misplacement	Rate of misplacement, occurring after patients removal from dorsal to lateral position	3 hours	Yes
Secondary	Rate of misplacement	Rate of misplacement, occurring during surgery, potentially caused by vibrations and movements by surgeons	3 hours	Yes
Secondary	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	Yes
Secondary	rate of fibreoptic bronchoscopy	Necessity of tube re-placement by fibreoptic bronchoscopy	3 hours	No
Secondary	Quality of lung collapse		3 hours	No
Secondary	Airway injuries		3 hours	Yes
Secondary	Postoperative coughing		24 hours	Yes
Secondary	Postoperative hoarseness		24 hours	Yes
Secondary	Postoperative sore throat		24 hours	Yes