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

NCT ID: NCT03144479

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-10
• Study Completion Date: 2017-12-31

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.

Conditions

Anesthesia; Thoracic Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Positioning of right-sided double lumen tube with fluoroscopy

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

Group Type: EXPERIMENTAL

right-sided double lumen tube

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

right-sided double lumen tube

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Device intervention : central venous catheter wire guide and radioscopy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Watremez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 10702432 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21802958 (View on PubMed)

Other Identifiers

2016/29dec/565

Identifier Type: -

Identifier Source: org_study_id