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

NCT03144479 | Completed

• 1 other identifier: 2016/29dec/565
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Thoracic Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  20 minutes

Secondary Outcomes (1)

• Total time spent to correctly position the right-sided double lumen tube

  20 minutes

Study Arms (2)

Positioning of right-sided double lumen tube with fluoroscopy

EXPERIMENTAL

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

Procedure: right-sided double lumen tube

Positioning of right-sided double lumen tube with fibroscope

EXPERIMENTAL

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

Procedure: right-sided double lumen tube

Interventions

right-sided double lumen tube 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

Also known as: Device intervention : central venous catheter wire guide and radioscopy

Positioning of right-sided double lumen tube with fibroscope; Positioning of right-sided double lumen tube with fluoroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (2)

• 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.

  PMID: 10702432 RESULT

• 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.

  PMID: 21802958 RESULT

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Christine Watremez, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: May 8, 2017
• Study Start: March 10, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)