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New Technique to Assess Correct Positioning of the Right-sided Double Lumen Tube

Primary Purpose

Anesthesia, Thoracic Diseases

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
right-sided double lumen tube
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients > 18 years old who have to undergo a left thoracic surgery with a one lung ventilation technique

Exclusion Criteria:

  • emergency surgical procedures, patients with predictable difficulties of insertion of a double-lumen endotracheal tube, hemodynamically unstable patients

Sites / Locations

  • Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Positioning of right-sided double lumen tube with fluoroscopy

Positioning of right-sided double lumen tube with fibroscope

Arm Description

positioning of the right-sided double lumen tube with a wire guide and fluoroscopy

positioning of the right sided double lumen tube in the same patient but with a fibroscope

Outcomes

Primary Outcome Measures

Measurement of the distance between the lateral orifice of the tube and the orifice of the right upper lobe bronchus
Fibroscopic measurement to assess the correct positioning of the right-sided double lumen tube with the wire guide and the fluoroscopy

Secondary Outcome Measures

Total time spent to correctly position the right-sided double lumen tube
If the technique with the wire guide and the fluoroscopy, takes more than 20 minutes to be achieved, it is considered as failed.

Full Information

First Posted
March 29, 2017
Last Updated
September 7, 2018
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03144479
Brief Title
New Technique to Assess Correct Positioning of the Right-sided Double Lumen Tube
Official Title
A New Technique to Assess the Correct Positioning of a Right-sided Double-lumen Tube Without Fiberoptic Bronchoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A technique not yet described in the literature and allowing anesthesiologists who do not regularly practice fibroscopy or who do not routinely have this type of apparatus for their procedures, to install straight double-lumen tubes without compromising the ventilation of the patient. The aim is to introduce a central venous catheter wire guide into the bronchial arm of the right double-lumen tube and insert it into the right upper lobe bronchus orifice under fluoroscopic control. Then, to validate the new technique, we will carry out a fibroscopic control.
Detailed Description
Right-sided double lumen tube (Mallinckrodt - Endobronchial tube) is introduced into the glottis via direct laryngoscopy. After the endotracheal lumen tube has passed the vocal cords, the stylet is removed, and the tube is rotated 90° toward the right and advanced slightly until resistance is encountered. Auscultation is then performed to check the proper side the endobronchial tube was inserted to. Then, the anatomy of the carina and the origins of the right and left upper bronchus are identified with the video-bronchoscopy. After a mild plication of the distal extremity of an adult central venous catheter wire guide (0.53mm diameter, 45cm length, one straight soft tip on one end and one "J" tip on other), the J-shaped extremity of this guide is introduced through the endobronchial lumen under direct video-bronchoscope. The wire guide is then slowly removed in order that proper alignment between the wire extremity and the right upper lobe occurs. The wire is removed again until its J-shaped extremity appears through the right-upper lobe ventilation orifice. In order to align the orifice of the tube with the upper lobe bronchus, a rotational movement of the double-lumen tube may be necessary. When the location of the orifice of the right upper lobe is identified, the guide is moved forward through the orifice into the upper lobe bronchus. Once satisfactory initial placement is achieved, the bronchial cuff is left inflated, the wire guide of the central venous catheter is kept in place in the upper lobe bronchus, and the patient is turned to the right lateral decubitus position. The proper positioning of the tube is once again checked by another video-bronchoscopy. To confirm the exact placement of the tube, a fiberoptic bronchoscopy is performed through the endobronchial lumen to find the right upper lobe ventilation orifice and confirm alignment. Then, it is placed distally to the endobronchial lumen to confirm a clear view showing the bronchus intermedius. After passing the fiberoptic bronchoscope through the tracheal lumen, the blue bronchial cuff is visualized at the origin of the right main stem bronchus below the level of the carina.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Thoracic Diseases

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positioning of right-sided double lumen tube with fluoroscopy
Arm Type
Experimental
Arm Description
positioning of the right-sided double lumen tube with a wire guide and fluoroscopy
Arm Title
Positioning of right-sided double lumen tube with fibroscope
Arm Type
Experimental
Arm Description
positioning of the right sided double lumen tube in the same patient but with a fibroscope
Intervention Type
Procedure
Intervention Name(s)
right-sided double lumen tube
Other Intervention Name(s)
Device intervention : central venous catheter wire guide and radioscopy
Intervention Description
Verification of a new technique to assess the correct positioning of a right-sided double-lumen tube for left thoracic surgeries, using a central venous catheter wire guide and a radioscopy
Primary Outcome Measure Information:
Title
Measurement of the distance between the lateral orifice of the tube and the orifice of the right upper lobe bronchus
Description
Fibroscopic measurement to assess the correct positioning of the right-sided double lumen tube with the wire guide and the fluoroscopy
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Total time spent to correctly position the right-sided double lumen tube
Description
If the technique with the wire guide and the fluoroscopy, takes more than 20 minutes to be achieved, it is considered as failed.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients > 18 years old who have to undergo a left thoracic surgery with a one lung ventilation technique Exclusion Criteria: emergency surgical procedures, patients with predictable difficulties of insertion of a double-lumen endotracheal tube, hemodynamically unstable patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Watremez, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10702432
Citation
Campos JH, Massa FC, Kernstine KH. The incidence of right upper-lobe collapse when comparing a right-sided double-lumen tube versus a modified left double-lumen tube for left-sided thoracic surgery. Anesth Analg. 2000 Mar;90(3):535-40. doi: 10.1097/00000539-200003000-00007.
Results Reference
result
PubMed Identifier
21802958
Citation
de Bellis M, Accardo R, Di Maio M, La Manna C, Rossi GB, Pace MC, Romano V, Rocco G. Is flexible bronchoscopy necessary to confirm the position of double-lumen tubes before thoracic surgery? Eur J Cardiothorac Surg. 2011 Oct;40(4):912-6. doi: 10.1016/j.ejcts.2011.01.070. Epub 2011 Jul 29. Erratum In: Eur J Cardiothorac Surg. 2012 Jun;41(6):1411. Lamanna, Carmine [corrected to La Manna, Carmine].
Results Reference
result

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New Technique to Assess Correct Positioning of the Right-sided Double Lumen Tube

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