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

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ClinicalTrials.gov Identifier: NCT01807676
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery Device: ET View Double Lumen Tube Device: conventional Double Lumen Tube Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
Study Start Date : March 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

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 Name: 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 Name: conventional DLT (Bronchocath, left sided; Rüsch, Kernen, Germany)




Primary Outcome Measures :
  1. time to intubation [ Time Frame: 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 :
  1. Rate of misplacement [ Time Frame: 3 hours ]
    Rate of misplacement, occurring after patients removal from dorsal to lateral position

  2. Rate of misplacement [ Time Frame: 3 hours ]
    Rate of misplacement, occurring during surgery, potentially caused by vibrations and movements by surgeons

  3. Rate of blind insertion [ Time Frame: 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

  4. rate of fibreoptic bronchoscopy [ Time Frame: 3 hours ]
    Necessity of tube re-placement by fibreoptic bronchoscopy

  5. Quality of lung collapse [ Time Frame: 3 hours ]
  6. Airway injuries [ Time Frame: 3 hours ]
  7. Postoperative coughing [ Time Frame: 24 hours ]
  8. Postoperative hoarseness [ Time Frame: 24 hours ]
  9. Postoperative sore throat [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807676


Locations
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Switzerland
University Hospital Zurich, Division of Anaesthesiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Division of Anaesthesiology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01807676     History of Changes
Other Study ID Numbers: 2012-0520
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014