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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT03144479
Collaborator
(none)
10
1
2
9.7
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: right-sided double lumen tube
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
A New Technique to Assess the Correct Positioning of a Right-sided Double-lumen Tube Without Fiberoptic Bronchoscopy
Actual Study Start Date :
Mar 10, 2017
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Positioning of right-sided double lumen tube with fluoroscopy

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

Procedure: right-sided double lumen tube
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
Other Names:
  • Device intervention : central venous catheter wire guide and radioscopy
  • Experimental: Positioning of right-sided double lumen tube with fibroscope

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

    Procedure: right-sided double lumen tube
    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
    Other Names:
  • Device intervention : central venous catheter wire guide and radioscopy
  • Outcome Measures

    Primary Outcome Measures

    1. Measurement of the distance between the lateral orifice of the tube and the orifice of the right upper lobe bronchus [20 minutes]

      Fibroscopic measurement to assess the correct positioning of the right-sided double lumen tube with the wire guide and the fluoroscopy

    Secondary Outcome Measures

    1. Total time spent to correctly position the right-sided double lumen tube [20 minutes]

      If the technique with the wire guide and the fluoroscopy, takes more than 20 minutes to be achieved, it is considered as failed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cliniques universitaires Saint-Luc Brussels Belgium 1200

    Sponsors and Collaborators

    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    Investigators

    • Principal Investigator: Christine Watremez, MD, PhD, Cliniques universitaires Saint-Luc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    ClinicalTrials.gov Identifier:
    NCT03144479
    Other Study ID Numbers:
    • 2016/29dec/565
    First Posted:
    May 8, 2017
    Last Update Posted:
    Sep 11, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 11, 2018