AnesthesiaNCT03144479
New Technique to Assess Correct Positioning of the Right-sided Double Lumen Tube
A study testing right-sided double lumen tube in people with Anesthesia and Thoracic Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Thoracic Diseases
- What is being tested?
- right-sided double lumen tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Mar 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients > 18 years old who have to undergo a left thoracic surgery with a one lung ventilation technique
Who cannot join
- emergency surgical procedures, patients with predictable difficulties of insertion of a double-lumen endotracheal tube, hemodynamically unstable patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Technique to Assess the Correct Positioning of a Right-sided Double-lumen Tube Without Fiberoptic Bronchoscopy
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.
Read the 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
- Being tested
- right-sided double lumen tube
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
right-sided double lumen tubeProcedure or surgery
Also called Device intervention : central venous catheter wire guide and radioscopy
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
| Study group | Role | What they receive |
|---|---|---|
| Positioning of right-sided double lumen tube with fluoroscopy | Experimental | positioning of the right-sided double lumen tube with a wire guide and fluoroscopy Receives: 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 Receives: Procedure: right-sided double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes
Secondary outcomes (1)
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start10 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Watremez, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144479
- Sponsor's protocol ID
- 2016/29dec/565
- Status last verified
- Sep 2018
- First submitted
- 29 Mar 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10702432de 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.
PubMed 21802958
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Technique to Assess the Correct Positioning of a Right-sided Double-lumen Tube Without Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT03144479
- Acronym / sponsor ID
- 2016/29dec/565
- Conditions
- Anesthesia, Thoracic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positioning of right-sided double lumen tube with fluoroscopy | Experimental | Procedure: right-sided double lumen tubepositioning of the right-sided double lumen tube with a wire guide and fluoroscopy |
| Positioning of right-sided double lumen tube with fibroscope | Experimental | Procedure: right-sided double lumen tubepositioning of the right sided double lumen tube in the same patient but with a fibroscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients > 18 years old who have to undergo a left thoracic surgery with a one lung ventilation technique
Key exclusion criteria (1 listed)
- emergency surgical procedures, patients with predictable difficulties of insertion of a double-lumen endotracheal tube, hemodynamically unstable patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| right-sided double lumen tubeAlso: Device intervention : central venous catheter wire guide and radioscopyVerification 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 | Procedure or surgery | Positioning of right-sided double lumen tube with fibroscope, Positioning of right-sided double lumen tube with fluoroscopy |
Primary outcome
Measurement of the distance between the lateral orifice of the tube and the orifice of the right upper lobe bronchus
Time frame: 20 minutes
Fibroscopic measurement to assess the correct positioning of the right-sided double lumen tube with the wire guide and the fluoroscopy
1 secondary outcome
Total time spent to correctly position the right-sided double lumen tube
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Results publication: PubMed 10702432Campos 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 publication: PubMed 21802958de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Watremez, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing right-sided double lumen tube in people with Anesthesia and Thoracic Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144479, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.