## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 2016/29dec/565
#### Organization
**Class:** OTHER
**Full Name:** Cliniques universitaires Saint-Luc- Université Catholique de Louvain
### Status Module
#### Completion Date
**Date:** 2017-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-09-11

**Type:** ACTUAL

**Last Update Submit Date:** 2018-09-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-03-10

**Type:** ACTUAL

**Status Verified Date:** 2018-09

#### Study First Post Date
**Date:** 2017-05-08
**Type:** ACTUAL
**Study First Submit Date:** 2017-03-29
**Study First Submit QC Date:** 2017-05-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cliniques universitaires Saint-Luc- Université Catholique de Louvain

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Anesthesia

- Thoracic Diseases

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: right-sided double lumen tube

**Label:** Positioning of right-sided double lumen tube with fluoroscopy

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Procedure: right-sided double lumen tube

**Label:** Positioning of right-sided double lumen tube with fibroscope

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Positioning of right-sided double lumen tube with fibroscope

- Positioning of right-sided double lumen tube with fluoroscopy

**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

**Name:** right-sided double lumen tube

**Other Names:**

- Device intervention : central venous catheter wire guide and radioscopy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Measurement of the distance between the lateral orifice of the tube and the orifice of the right upper lobe bronchus

**Time Frame:** 20 minutes

#### Secondary Outcomes

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

**Measure:** Total time spent to correctly position the right-sided double lumen tube

**Time Frame:** 20 minutes

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Brussels

**Country:** Belgium

**Facility:** Cliniques universitaires Saint-Luc

**Zip:** 1200

#### Overall Officials

**Official 1:**

**Affiliation:** Cliniques universitaires Saint-Luc

**Name:** Christine Watremez, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 10702432

**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].

**PMID:** 21802958

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16655

- Name: Thoracic Diseases

- Relevance: HIGH

- As Found: Thoracic Diseases

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013896

- Term: Thoracic Diseases

### Misc Info Module

- Version Holder: 2024-05-24
